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Basel, June 4, 2021 Novartis today announced the first published mature overall survival (OS) and updated overall response rate (ORR) data following treatment with Tabrecta (capmatinib) in adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14)1-3. Data from the ongoing, pivotal, multi-cohort Phase II GEOMETRY mono-1 study will be presented today during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Poster Discussion Session, Lung CancerNon-Small Cell Metastatic; June 4, 2021, 9:00 AM-10:00 AM CT; abstract 9020).

This new analysis further supports Tabrecta as a cornerstone targeted treatment for METex14 NSCLC patients and highlights the importance of biomarker testing, said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, and lead investigator of the GEOMETRY study. The impressive overall survival outcome and confirmed outstanding response in the first-line setting will help oncologists decide upon a therapeutic option for patients.

The analysis includes new data from the treatment-nave (1L) expansion cohort 7 and previously-treated (2L+) cohort 6, and mature data from previously-reported cohorts, for a total of 160 patients1,2.

The introduction of Tabrecta a year ago dramatically changed the treatment landscape for patients with METex14 NSCLC. Now we have further evidence that Tabrecta, the market-leading treatment specifically for METex14 NSCLC patients4, has the potential to help people live longer, said Jeff Legos, Senior Vice President, Head of Oncology Drug Development, Novartis Oncology.

The results presented today provide additional data on the efficacy of Tabrecta in both treatment-nave and previously-treated patients with METex14 metastatic NSCLC 2:

No new safety signals or unexpected safety findings were observed. Ninety-eight percent of subjects had at least one adverse event (AE) of any grade and 50.9% of subjects had at least one serious adverse event (SAE). Thirteen percent were suspected to be treatment-related. The most common adverse events (>20%, all grades) across all cohorts were peripheral edema, nausea, vomiting, increased blood creatinine, dyspnea, fatigue and decreased appetite. The majority of AEs were grade 3 or 42.

Currently, the five-year survival rate for lung cancer is less than 20%5, decreasing further when the disease is diagnosed at later stages6. Nearly one in three patients with metastatic NSCLC may have an actionable mutation7,8. METex14 has been reported to occur in 3%-4% of metastatic NSCLC cases9. Many patients with mutations that lead to METex14 are not diagnosed with NSCLC until their disease has progressed to later stages and often have poor prognosis10,11.

A separate analysis of patient-reported outcomes (PROs) evaluated cough, delayed time to lung symptom deterioration, and quality of life (QoL) in NSCLC patients with METex14 (abstract 9056)3.

Additionally, a retrospective analysis of GEOMETRY mono-1 validates the clinical utility of liquid biopsy testing to identify METex14 positivepatientsfor treatment withTabrecta (Poster Session: Lung CancerNon-Small Cell Metastatic; abstract 9111)12.

Visithttps://www.hcp.novartis.com/virtual-congress/a-2021/ for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO21 Virtual Scientific Program data presentations (for registered participants).

About GEOMETRY mono-1GEOMETRY mono-1 is a Phase II a multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, ALK-negative rearrangement, metastatic NSCLC harboring mutations that lead to MET exon-14 skipping who received capmatinib tablets 400 mg orally twice daily.

Patients were assigned to cohorts on the basis of MET status and previous lines of therapy13. The primary endpoint was overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) evaluated by BIRC.

About Tabrecta (capmatinib)Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications. In May 2020, Tabrecta was approved by the US Food and Drug Administration (FDA) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

In June 2020, Tabrecta was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test.Tabrecta was also approved in Hong Kong in February 2021 and Switzerland in April 2021.

Novartis and Lung CancerLung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year14. There are two main types of lung cancer small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)15,16. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 2 million new cases each year14,16.More people die of lung cancer every year than any other cancer type14. Treatment options are limited for people with lung cancer who experience cancer growth or progression while on current standard of care treatments17-19.

Novartis is committed to developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine and the role of newer core immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust in the industry. Novartis research activities are informed by our long-term relationships with leading lung cancer thought leaders and patient advocates. With them, Novartis is committed to reimagining the treatment of lung cancer.

IndicationTABRECTA (capmatinib) tablets is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery (metastatic), and whose tumors have an abnormal mesenchymal-epithelial transition (MET) gene.

The effectiveness of TABRECTA in these patients is based on a study that measured 2 types of response to treatment (response rate and duration of response). There is no clinical information available to show if patients treated with TABRECTA live longer or if their symptoms improve. There are ongoing studies to find out how TABRECTA works over a longer period of time.

It is not known if TABRECTA is safe and effective in children.

Important Safety InformationTABRECTA may cause serious side effects, such as lung or breathing problems. TABRECTA may cause inflammation of the lungs during treatment that may lead to death. Patients should be advised to contact their health care provider right away if they develop any new or worsening symptoms, including cough, fever, trouble breathing, or shortness of breath.

TABRECTA may cause abnormal blood test results, which may be a sign of liver problems. Patients should be advised that their health care provider will do blood tests to check their liver before starting and during treatment with TABRECTA. Patients should be advised to contact their health care provider right away if they develop any signs and symptoms of liver problems including the skin or the white part of their eyes turning yellow (jaundice), dark or tea-colored urine, light-colored stools (bowel movements), confusion, loss of appetite for several days or longer, nausea and vomiting, pain, aching, or tenderness on the right side of the stomach area (abdomen), or weakness or swelling in the stomach area.

The skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Patients should be advised to use sunscreen or wear clothes that cover their skin during treatment with TABRECTA to limit direct sunlight exposure.

For women of reproductive potential, TABRECTA can harm their unborn baby. They should use an effective method of birth control during treatment with TABRECTA and for 1 week after the last dose. Men who have partners who can become pregnant should use effective birth control during treatment with TABRECTA and for 1 week after the last dose.

Before taking TABRECTA, patients should tell their health care provider about all their medical conditions, including if they have or have had lung or breathing problems other than lung cancer, have or have had liver problems, or if they are pregnant or plan to become pregnant, as TABRECTA can harm their unborn babies. Females who are able to become pregnant should have a pregnancy test before they start treatment with TABRECTA and should use effective birth control during treatment and for 1 week after the last dose of TABRECTA. Patients should be advised to talk to their health care provider about birth control choices that might be right for them during this time and to tell their health care provider right away if they become pregnant or think they may be pregnant during treatment with TABRECTA. Males who have female partners who can become pregnant should use effective birth control during treatment and for 1 week after their last dose of TABRECTA.

Patients should tell their health care provider about all the medicines they take or start taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of TABRECTA include swollen hands, ankles, or feet (peripheral edema); nausea and/or vomiting; tiredness and/or weakness (fatigue, asthenia); shortness of breath (dyspnea); loss of appetite; changes in bowel movements (diarrhea or constipation); cough; pain in the chest; fever (pyrexia); back pain; and decreased weight.

Please see full Prescribing Information for Tabrecta available athttps://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com/.

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References

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Excerpt from:
Novartis announces Tabrecta first published overall survival and updated overall response data in patients with METex14 - GlobeNewswire

Basically, Modi has followed a policy of surreptitiously taxing the middle class and poor, through indirect taxes such import duties on consumer goods, excise duties on petroleum products, and across the board duty protection to commodity producers, and funneling this pool

of taxes to fund subsidies and tax cuts to corporates.

The amounts involved are not small. A rough estimate is that incremental duties on petroleum products alone amount to incremental taxation on consumers to the extent of about INR, 2 Trillion or about 1% of GDP. Add up all of them, and my guess is that since 2014, consumers have been taxed to the extent of 2% of GDP, directly or indirectly, and these funds have largely gone to the corporate sector via tax cuts and other subsidies, disguised either as protection from imports and/or production linked incentives.

As you can see from the Graph of disposable income of consumers, Modis tax measures have flattened consumers disposable income since 2018. Given the general slump in the economy, the prospects of a consumer led recovery in the economy are pretty slim. Also not shown here for lack of space, there is considerable evidence that consumers had binged on credit before 2018 and are now de-leveraging.

The fact is that if the 2% of GDP that has been skimmed from consumers to the corporate sectors had led to an similar increase in private investment in the economy, GDP growth would not have tapered off, and the need for Govt to prop up growth through borrowings, would not arise. But the harsh fact is, while tycoons love the additional profit bonanza coming their way, they have used these to pair down borrowings, rather than invest, and this shows the extent of their faith in the sustainability of Modis policies. His capricious decision making doesnt inspire confidence either.

So the 2% of GDP that Modi has scrounged from the middle class and gifted to tycoons has borne no fruit for the economy. Perhaps not even for Modi, unless you count buoyant contributions to anonymous electoral bonds as returns. Incidentally, they have proved to be the best investment for tycoons considering the 2% in GDP that has accrued to them as windfall profits in return.

On the employment front, the situation is rather alarming. First consider the big picture before the pandemic as shown in the graph on employment.

Employment rate has been falling since 2012, and has further dropped from 49.9% in 2014, to 47.3 in 2019. Each percentage drop in employment rate translates roughly into half a million jobs lost. These job losses are in the organized sector only.

In the un-organized sector for which no statistics are available, on a conservative basis, a percentage point drop in employment rate means job losses of about 2.5 million. Since 2014, India has lost about 6 million jobs in the economy, before the pandemic struck. Forget about job growth for a growing population. We have fewer jobs now than in 2014.

Read the original here:
The poor and the middle class taxed like never before by the '56 inch' economy - National Herald

TYLER TxDOT is planning to conduct the following construction and maintenance work in the district during the Week of June 7, 2021. Work schedules are subject to change due to weather conditions, equipment failure, or other unforeseen issues. Slow down and pay attention in work zones.

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Seal coat operations continue around the Tyler District. Motorists should expect lane closures and delays during this work to seal and protect roadways from water, and to provide a longer life cycle. Various project work will be conducted with slow-moving mobile operations. Crews will be working in Cherokee, Henderson, Rusk, and Van Zandt counties throughout the week. Information on specific work locations is available in the Van Zandt County section of this release.

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Anderson County Palestine Maintenance plans to conduct base repairs and level up on FM 3224. Expect lane closures with flaggers and a pilot car managing traffic control.

Anderson County construction projects updates:

County Road Off-System Bridge Project

Limits: Various locations in Anderson County

Contractor: Stateline Construction, LLC

Cost: $1.5 million

Anticipated Completion Date: Summer 2021

Final cleanup activities are ongoing on the CR 458 and CR 468 bridges and roadway elements. The project consists of construction of bridges, storm sewer, guardrail, base, pavement surfaces, and pavement markings.

US 79 Super 2 Project

Limits: From 0.5 mile northeast of Loop 256 to the Anderson/Cherokee County line

Contractor: Madden Contracting Company, LLC

Cost: $14.4 million

Anticipated Completion Date: Spring 2022

Work is ongoing on the shoulders and driveways, and to place drainage structures. The work zone speed limit is 60 mph. Expect lane closures and delays. The project is widening for a Super 2, and includes sub-grade work, surface treatment, base and surface hot-mix asphalt, widening structures, bridge rail, metal beam guard fence, signage, and permanent striping.

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Cherokee County Jacksonville Maintenance plans to continue edge work on FM 23. Expect lane closures with flaggers managing traffic. Ditch maintenance is planned on roads around the county.

Cherokee County construction projects updates:

FM 22 Safety Widening and Bridge Replacement Project

Limits: From CR 1512 west of Gallatin, east to SH 110

Contractor: Stateline Construction, LLC

Cost: $5.5 million

Anticipated Completion Date: Summer 2022

The contractor is scheduled to continue bridge construction at Sandy Creek. The road is closed to traffic. Motorists should follow the marked detour route to navigate through the area. The project will widen the existing roadway, replace three bridges, and incorporate safety upgrades.

US 84 Widening

Limits: From 0.43 mi east of SH 110 in Rusk, northeast to the Rusk County line in Reklaw

Contractor: Madden Contracting Company, LLC

Cost: $7.9 million

Anticipated Completion Date: Summer 2022

The contractor is scheduled to continue right-of-way clearing. Expect lane closures with delays possible. The project will widen and resurface the roadway, and add safety upgrades.

FM 235 Safety Widening

Limits: From SH 110 going east to FM 2274

Contractor: Madden Contracting Company, LLC

Cost: $3.5 million

Anticipated Completion Date: Fall 2021

The contractor is scheduled to continue drainage upgrades. Expect lane closures with a pilot car managing traffic. The project will widen the existing roadway and incorporate safety upgrades.

FM 241 Safety Widening

Limits: From US 69 going southeast to SH 21

Contractor: A. L. Helmcamp, Inc.

Cost: $5.5 million

Anticipated Completion Date: Summer 2021

The contractor is scheduled to perform cleanup activities on this project that is widening the existing roadway and incorporating safety upgrades.

County Road Bridge Replacement Project

Limits: CR 2905 at Bowles Crk; CR 2614 at Beans Crk; CR 1504 at Turnpike Crk; CR 3203 at Mills Crk.

Contractor: Stateline Construction, LLC

Cost: $1.9 million

Anticipated Completion Date: Spring 2021

No work is scheduled on CR 3203 and CR 1504. Both roadways are open to traffic. Construction of the new bridges is ongoing on CR 2905 and CR 2614. Both roads are closed to through traffic. The projects are replacing the existing bridges at each location with new structures.

SH 204 Super-2 Widening Project

Limits: From US 79 in Jacksonville southeast to SH 110

Contractor: Madden Contracting Company, LLC

Cost: $13.7 million

Anticipated Completion Date: Summer 2021

The contractor is scheduled to perform seal coat and paving work as well as concrete driveway installation. Expect lane closures with a pilot car managing traffic. The project is adding passing lanes and includes safety upgrades.

US 69 Sidewalks in Jacksonville

Limits: From Nacogdoches St. to Tena St. in Jacksonville

Contractor: Highway 19 Construction, LLC

Cost: $507,099.00

Anticipated Completion Date: Spring 2021

No work is scheduled. The project is constructing sidewalks along US 69 in Jacksonville.

US 79 Rehabilitation Project

Limits: From 0.16 mile east of SH 110 to the Mud Creek Relief Bridge

Contractor: Madden Contracting Company, LLC

Cost: $8.2 million

Anticipated Completion Date: Spring 2021

The contractor plans to begin replacing the bridge joints. Expect lane closures and delays. The work zone speed limit is 60 mph. The project is rebuilding the roadway pavement and upgrading bridge rail.

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Gregg County Longview Maintenance plans to conduct ditch cleaning operations on FM 1252 near the county line. Expect lane closures with flaggers providing traffic control. Weather permitting, bridge repairs will continue on various roadways around the county.

Gregg County construction projects updates:

I-20 Upgrades at Barber Road (New Project)

Limits: Exit and Entrance ramps to Barber Road

Contractor: Longview Bridge and Road

Cost: $1.49 million

Anticipated Completion Date: August 2021

The contractor will be working on drainage upgrades and driveways during night work. Motorists can expect lane closures on I-20 as well as alternating ramp closures, and delays, from 8 p.m. to 6 a.m. The project consists of widening of entrance and exit ramps, culverts, drainage upgrades, new metal beam guard fence and bridge rails on the Barber Road overpass, and an asphalt overlay.

US 80 Improvements Project

Limits: Eastman Road to 1 mile east

Contractor: Longview Road and Bridge

Cost: $1.09 million

Anticipated Completion Date: July 2021

Night work gets underway June 1 on this project that consists of constructing concrete curb and gutter in key locations in the median, an asphalt overlay, new signs, and striping. Construction will be conducted from 9 p.m. to 6 a.m., Sunday through Thursday nights. Expect lane closures and delays.

FM 2204, etc., Safety Improvement Project

Limits: US 259 Bypass to SH 322

Contractor: Stateline Construction

Cost: $3.88 million

Anticipated Completion Date: November 2021

The contractor will be working on drainage upgrades and driveways. Expect lane closures and delays. This project consists of culverts, safety end treatments, drainage upgrades, new metal beam guard fence and driveway asphalt.

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Project updates for the Week of June 7, 2021 - Texas Department of Transportation

China wants its young people to have more babies, but for some of the country's millennials, procreation couldn't be further from their minds.

This week's announcement of the three-child policy, aimed at encouraging couples in China's urban areas to have three children, has been met with ridicule.

Many social media users notedthey couldn't begin to afford a second child, let alone a third, in a country where a strict one-child policy has dramatically shaped the society.

On Weibo, user Sivan said: "I dare not have even one child, what's the point of talking about three?"

In fact, even before the family planning news broke, young people were opting in to anew social trend that is all about checking out from society and its pressures "tang ping", or "lying flat".

Lying flatrefers to a defeatist lifestyle, where peoplestop working, desiring material acquisition, and tap out ofany social life sometimes for good.

A declining birth rate and a rapidly ageing population loomas China's most pressing crises for the years to come.

The phrase has been coined by the young generationin response to increasing social anxiety and pressure, andaround the push to have more children, as well as the increasingly unaffordable associated costs.

Critics believe by lying flat, young people are participating in a kind of non-cooperationmovement,rather than surrendering themselves to China's oppressive work culture where they see little hope of social mobility.

For more than 35 years from 1980, couples in China's urban areas were prohibited from having more than one child, and faced large fines, or even forced abortion and sterilisation if caught.

The country eased that and moved to a two-child policy in 2015.

Now, China wants families to have three children, as it looksto boost its population after it was recently revealed the country's population growthhad dipped to its slowest pacesince the 1960s.

Immediately before the release of the three-child policy, several state media outlets in China published articles criticisinglying flatand called the trend shameful.

Shenzhen, widely regarded as China's Silicon Valley, is notorious for its 996 working culture, but a new policy that enforces paid leave and overtime payments for special industries could help reduce burnout.

Related social media groups havealso been censored.

On May 30, social media platform Doubanremoved a popular lying flatgroup, and many posts containingthe phrase were deleted.

Comments on China's social media platform Weibo following state media Xinhua's post on the three-child policy were quickly removed.

Another online votewas deleted after over 90 per cent of people ticked a box saying they would not consider a third child at all.

However, that has not shut down discussion another lying flatgroup on social media platform Baidu Tiebanow has over 180,000 members.

Reuters: Aly Song

Lucy Yu, 32, lives in Beijing and is expectingtwins in September.

In Lucy's eyes, lying flatis a fantasy.

Sheuses the phrase all the time but can never practiseit in reality.

"I use the word to mock myself, like others do too, but then just continue with what I've been doing," she said.

"It's a way young people come up with self-mockery. When we are too tired or feel a great deal of pressure, we want to 'lie flat'for a moment and leave the hard work behind.

"It's just a saying. How could you really lie flat?"

This is how Chinese women defied one-child policy to give birth in secret.

Ms Yu chatted with colleagues who are older than her they were born in the 1970safter the new policy was announced.

"They actually wanted a second child, but the two-child policy came too late," she said.

"That generation had siblings and they were relatively more affluent, but they didn't havethe chance."

But for younger people, it's a different story.

"Ordinary city, working-class people are struggling to make ends meet, so when the three-child policy comes out, they tend to feel that it's none of their business," she said.

"It's too tiresome and only creates unnecessary burdens for ourselves.

"I haven't counted how much money it will cost to have two children, but I'll raise them in a rich way if I have money, and raise them in a poor way if I don't have money. They'll grow up anyway."

Supplied

Anabel Ye is a 20-year-old university college student majoring in finance management, who identifies herself as one of the lying-down youth.

"I am a bit lying down already. There are too many amazing people everywhere," she said.

"Often, I found my efforts were not rewarded. Again and again, my passions were grounded."

Ms Ye believes the new policycould lead to a better future for China, but worries about the concerns it causes for the younger generation.

"I think the mortality rate of young people is also getting higher, many people died young because of physical and psychological issues associated with high pressure," she said.

She might have children in the future, but only one or two, and that willdepend on her circumstances.

"To give a child a good family and educational environment is not easy today, apart from that I also have to work. I don't think I'll have time and energy [to have more]," she said.

"Two children is ideal, but I also fear I might not want to get married or have children because of the increasing pressure."

Reuters:Guang Niu/GN/CP

Guo Fei, a professor of managementat Macquarie University's Centre for Workforce Futures, thinks the increased child limit is a good idea, but is uncertain if it will have the desired outcome.

"China's low fertility started, actually, [at]the same timewhen China started to experience rapid economic growth, and rapid urbanisation and modernisation," she said.

"The low fertility rate was not only the result of the one-child policy."

ProfessorGuo said the underlying reasons for China's low fertility wereactually socioeconomic.

Cost of living pressures are making things likeeducationbecomeunaffordable for many, and that has been deterring many from becoming parents.

Professor Guo thinks improving parental leave arrangements could help.

"If it's the company's burden, then couples or mothers who will have children will be discriminated against, they will be disadvantaged, because enterprise will be paying for their leave," she said.

"It's a norm and cultural attitude problem. In addition to the economic incentive, they also need to change attitudes towards childbearing women and older childbearingcouples."

If China doesn't do more to encourage people to have children, it could end up like South Korea, which has a negative fertility rate.

Butthose with the financialmeans will likely embrace the chance to have larger families, Professor Guo said.

"From the data we have from looking at the second child [policy], we have started to see women who have resources and higher education the well-off women tend to have higher intention to have a second child."

Reuters: Tingshu Wang

Wang Yaqiu, a China researcher fromHuman Rights Watch, has recently investigated China's previous two-child policy and gender discrimination in the workplace.

MsWang found the three-child policy might lead to companiesbecomingeven less willing to hire women.

Gender discrimination in the workplace worsened when the one-child policy was replacedwith the two-child policy.

"For 35 years, most professional women were only expected to take one period of maternity leave and had one child to take care of at home. That's what employers expect," Ms Wang said.

"When you hire a woman, if she already has a child, you know that she's not going to take another maternity leave.

"Companies started to worry. That makes companies even less willing to hire women."

China's government announcesit is scrapping a policy limiting couples to two children and will now allow them to have three.

Like Professor Guo, Ms Wang thinks a parental leave scheme andanti-discrimination laws need to be implemented along with the three-child policy.

"There is an issue with pregnancy-based firing at jobs," she said.

"It could be worse because now employers could potentially expect three maternity leaves."

Because there is no mandatory paternity leave,organisations don't face the same outlay forfathers who arehaving a child, so it's seen more costly to hire women than men in China.

To fix this, China needs to make equitable parental leaves for both men and women, Ms Wang said.

She believes the backlash against the three-child policy from the lying flat followers isfor two reasons.

"There are a lot of concerns with access to education, access to housing, access to health care, are those practical reasons that people don't want to have children."

The other reason, according to Ms Wang, is that the trauma left by the one-child policy still haunts many families today.

"To a lot of familiesit was the policy enforced in such a brutal way, through forced abortion, forced sterilisation. Now, the government found that the policy resulted in an aging population and we want more children," she said.

"Of course, people are going to become cynical'You controlled my body for so long, now you want me to go the other direction?'"

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China's three-child policy is designed to bring on a baby boom, but its young adults are 'lying flat' - ABC News

86% Overall Response Rate (ORR) and 43% Complete Response Rate in Immune Checkpoint Inhibitor (ICI) Nave Advanced Melanoma Patients in IOV-COM-202 Clinical Study

Initial 7 Patients Show 3 Complete Responses, 3 Partial Responses and 1 Best Response of Stable Disease

ASCO Update Conference Call and Webcast on Sunday, June 6 at 12 p.m. ET

SAN CARLOS, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced melanoma. The data are now available in an ePoster at the ASCO 2021 Annual Meeting.

Antonio Jimeno M.D., Ph.D., Professor of Medicine/Oncology and Otolaryngology at the University of Colorado School of Medicine stated, Anti-PD-1 therapy has become standard of care in frontline melanoma, yet we are still looking for ways to help more patients respond and to improve upon the depth and durability of responses. The 86% Overall Response Rate (ORR) for lifileucel in combination with pembrolizumab is remarkable and suggests a potential additive effect for early-line treatment of patients with melanoma. I look forward to investigating this treatment approach in additional patients with melanoma as well as in other tumor types such as head and neck squamous cancer.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, We are very pleased with the initial efficacy and safety results for lifileucel in combination with pembrolizumab in patients who are nave to anti-PD-1 therapy. We are particularly impressed by the complete response observations and noted conversion of several partial to complete responses over time. These data in melanoma also build upon our initial data for TIL in combination with pembrolizumab in head and neck cancer, supporting the broader potential for TIL in earlier anti-PD-1 nave treatment settings across indications.

Early data suggest the response rate of lifileucel plus pembrolizumab may be additive and confirm the potential feasibility and activity of this combination in patients with immune checkpoint inhibitor (ICI)-nave advanced melanoma. Cohort 1A in the IOV-COM-202 study is evaluating lifileucel in combination with pembrolizumab in patients who are nave to ICI, or anti-PD-1, therapy. Initial patients (n=7) enrolled in Cohort 1A had high tumor burden at baseline, and 71.4% had not received any prior systemic therapy.

Six of the seven patients had a confirmed objective response, representing an 86% ORR (2 complete responses (CR), 1 unconfirmed CR (uCR) who had not yet reached the confirmatory CR assessment, and 3 partial responses (PR)), with one best response of stable disease. Responses deepened over time and the CR/uCR rate was 43%. Poster data extraction was in April 2021 and the median follow up was 8.2 months. ORR was investigator-assessed per RECIST 1.1. In a subsequent data cut in May 2021, all ongoing responses continued.

The Cohort 1A results also demonstrated that lifileucel can be safely combined with pembrolizumab. The treatment-emergent adverse event (TEAE) profile was consistent with the underlying disease and known adverse event (AE) profiles of pembrolizumab, non-myeloablative lymphodepletion (NMA-LD) and IL-2. The median number of doses of IL-2 and pembrolizumab were six and 10, respectively.

Webcast and Conference CallIovance will host a webcast and conference call on Sunday, June 6, at 12:00 p.m. ET to discuss ASCO clinical data updates for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma. Iovance senior leadership, together with Dr. Omid Hamid of The Angeles Clinic, will present a summary of the ASCO data from Cohort 1A in the IOV-COM-202 study as well as the upcoming oral presentation of updated Cohort 2 data from the C-144-01 clinical study.

The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 4858337. The live webcast can be accessed in the Investors section of the companys website at http://www.iovance.com. The archived webcast will be available for a year in the Investors section at http://www.iovance.com.

AboutIovance Biotherapeutics, Inc.Iovance aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patients own immune cells to attack cancer. TIL cells are extracted from a patients own tumor tissue, expanded through a proprietary process, and infused back into the patient. Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in pivotal programs in patients with metastatic melanoma and cervical cancer. In addition, the companys TIL therapy is being investigated in a registration-supporting study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC). Clinical studies are also underway to evaluate TIL in earlier stage cancers in combination with currently approved treatments, and to investigate Iovance peripheral blood lymphocyte (PBL) T cell therapy for blood cancers. For more information, please visit http://www.iovance.com.

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our) within the meaning of the Private Securities Litigation Reform Act of 1995 (the PSLRA). All such written or oral statements made in this press release, other than statements of historical fact, are forward-looking statements and are intended to be covered by the safe harbor for forward-looking statements provided by the PSLRA. Without limiting the foregoing, we may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, forecast, guidance, outlook, may, could, might, will, should or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of managements experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the effects of the COVID-19 pandemic; risks related to the timing of and our ability to successfully develop, submit, obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval of, or other action with respect to, our product candidates, and our ability to successfully commercialize any product candidates for which we obtain FDA approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the new version of the protocol which further defines the patient population to include more advanced patients in our cervical cancer trial may have an adverse effect on the results reported to date; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA may differ from the interpretation of such results or communications by the FDA; the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved; our ability or inability to manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk that unanticipated expenses may decrease our estimated cash balances and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control.

CONTACTS

Iovance Biotherapeutics, Inc:Sara Pellegrino, IRCVice President, Investor Relations & Public Relations650-260-7120 ext. 264Sara.Pellegrino@iovance.com

Solebury Trout:Zara Lockshin646.378.2960zlockshin@soleburytrout.com

Read more:
Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Combination with Pembrolizumab in Advanced Melanoma at ASCO - GlobeNewswire