Leapfrog­ging ri­vals, Roche's Tecen­triq plus chemo nabs PFS end­point in front­line lung can­cer seg­ment

Roche has nabbed the first shot at a front­line in­di­ca­tion for a sig­nif­i­cant share of the all-im­por­tant lung can­cer mar­ket with to­day’s news that their check­point Tecen­triq hit the pri­ma­ry end­point on pro­gres­sion-free sur­vival for squa­mous non-small cell lung can­cer. Some an­a­lysts say that in­di­ca­tion could be worth more than a bil­lion dol­lars a year in added rev­enue.

San­dra Horn­ing

Re­searchers com­bined Tecen­triq with Abrax­ane-based chemo and com­pared it to chemo in first line pa­tients with ad­vanced NSCLC. At an in­ter­im point the com­bi­na­tion beat out chemo on PFS with a sta­tis­ti­cal­ly sig­nif­i­cant out­come but had yet to show an over­all sur­vival ben­e­fit. In­ves­ti­ga­tors will now keep on track­ing re­sults to see how OS mea­sures out.

There were no da­ta points in Roche’s state­ment. The pos­i­tive PFS re­sults, though, give Roche a chance to march ahead of a bevy of com­pe­ti­tion from Mer­ck, Bris­tol-My­ers Squibb and oth­ers in a key can­cer mar­ket where the com­pe­ti­tion has been in­tense. And they’ll like­ly get a help­ing hand from the FDA, which has been ea­ger to stamp these check­points from the ma­jor play­ers with ac­cel­er­at­ed ap­provals.

Jef­feries rushed out a note ear­ly Tues­day high­light­ing some block­buster po­ten­tial for Roche, which has been scram­bling to catch up with the lead­ers in check­point in­hi­bi­tion and looked to gain a first-to-mar­ket ad­van­tage here. They note:

IM­pow­er131 is an im­por­tant study for Roche. Squa­mous cell NSCLC, which ac­counts for c.25%-30% of NSCLC, is a more com­pli­cat­ed dis­ease than non-squa­mous NSCLC and there are few­er treat­ment op­tions. Roche has pre­vi­ous­ly not­ed that it could be first to mar­ket in the 1L squa­mous NSCLC set­ting if IM­pow­er131 pro­duced a su­pe­ri­or re­sult. We cur­rent­ly mod­el $1.1bn of peak sales for Tecen­triq in this 1L squa­mous set­ting and have pre­vi­ous­ly high­light­ed that a pos­i­tive re­sult from the tri­al could see 1%-3% up­side to EPS and val­u­a­tion.

Mer­ck and Bris­tol-My­ers have tak­en the lead role in the over­all lung can­cer mar­ket, but none of the com­pe­ti­tion is ced­ing con­trol. IM­pow­er131 is one of five Phase III read­outs that Roche has for lung can­cer this year. And three more are in the clin­ic. Dur­ing their Q4 re­view last month, Roche phar­ma chief Daniel O’Day sound­ed bull­ish on Roche’s chances of carv­ing out a big piece of the mar­ket for it­self.

Their on­go­ing stud­ies, he said, “will di­men­sion­al­ize the first-line lung can­cer space in 2018.”

“I’m con­vinced there will be mul­ti­ple op­tions for dif­fer­ent pa­tient types in this set­ting which ac­counts for around 45% of the lung can­cer set­ting. I’m al­so con­vinced that we’ll play a very im­por­tant role there.”

That won’t come easy, though. Roche’s lat­est win in Phase III is its third in a mat­ter of months, but with 5 check­points on the mar­ket, every­one is promis­ing to play hard to beat the com­pe­ti­tion. And be­ing first may be an ad­van­tage, but it’s no guar­an­tee of mar­ket suc­cess. Mer­ck is al­so ex­pect­ed to pro­vide a read out in the same can­cer seg­ment soon from KEYNOTE-407.

“Squa­mous non-small cell lung can­cer is dif­fi­cult to treat and there have been lim­it­ed new treat­ment op­tions over the last few decades,” said San­dra Horn­ing, Roche’s chief med­ical of­fi­cer and head of glob­al prod­uct de­vel­op­ment. “We will share the IM­pow­er131 re­sults with glob­al health au­thor­i­ties and we look for­ward to see­ing more ma­ture over­all sur­vival da­ta.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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