Roche stacks up Tecen­triq nods, fol­low­ing up breast can­cer ap­proval with small cell lung can­cer

Roche is carv­ing it­self a tidy niche with Tecen­triq in can­cer pock­ets that oth­er im­munother­a­pies haven’t yet con­quered. Af­ter scor­ing ap­proval in front­line use for breast can­cer last week, the Swiss drug­mak­er on Tues­day said the check­point in­hibitor has se­cured the FDA nod as a first-line treat­ment for ex­ten­sive-stage small cell lung can­cer (ES-SCLC).

Tecen­triq will be added to chemother­a­py — car­bo­platin and etopo­side — as the first new op­tion in more than two decades for treat­ment-naive pa­tients whose small cell lung can­cer has spread, Roche said, adding that the mon­o­clon­al an­ti­body is the on­ly can­cer im­munother­a­py to win ap­proval in this dif­fi­cult-to-treat cat­e­go­ry of pa­tients.

Lung can­cer — which en­com­pass­es small cell lung can­cer (SCLC) and non-small cell lung can­cer (NSCLC) — caus­es the high­est num­ber of can­cer-re­lat­ed fa­tal­i­ties glob­al­ly, the WHO es­ti­mates. SCLC, some­times called oat cell can­cer, ac­count for 10% to 15% of all lung can­cers, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety.

The Tecen­triq ap­proval was based on the Phase III IM­pow­er133 study, the re­sults of which were pub­lished last Sep­tem­ber. Da­ta showed that Tecen­triq in com­bi­na­tion with chemother­a­py helped peo­ple live sig­nif­i­cant­ly longer com­pared to chemother­a­py alone (me­di­an over­all sur­vival=12.3 vs. 10.3 months, re­spec­tive­ly; p=0.0069), and the Tecen­triq com­bo al­so sig­nif­i­cant­ly re­duced the risk of dis­ease wors­en­ing or death com­pared to chemother­a­py alone (PFS=5.2 ver­sus 4.3 months, re­spec­tive­ly; p=0.017).

In the Unit­ed States, Tecen­triq is al­ready ap­proved as a monother­a­py or a com­bo in oth­er types of lung can­cer pa­tients in­clud­ing the ini­tial (first-line) treat­ment of adults with metasta­t­ic non-squa­mous NSCLC with no EGFR or ALK ge­nom­ic tu­mour aber­ra­tions as well as metasta­t­ic NSCLC pa­tients whose dis­ease has pro­gressed dur­ing or fol­low­ing plat­inum-con­tain­ing chemother­a­py.

Roche’s Tecen­triq still has much to do be­fore it catch­es up with de fac­to lead­ers: Mer­ck’s $MRK Keytru­da and Bris­tol-My­ers’ $BMY Op­di­vo, but its strat­e­gy of nab­bing in­di­ca­tions over­looked or ahead of the oth­ers could help es­tab­lish it as a key play­er in the in­creas­ing­ly crowd­ed field.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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