Why wait? FDA gives ear­ly OK to Mer­ck’s Keytru­da for front­line lung can­cer

That didn’t take long.

Two weeks af­ter Mer­ck $MRK made a tri­umphant vic­to­ry march against Bris­tol-My­ers Squibb on the front­line non-small cell lung can­cer front at ES­MO, the FDA has fol­lowed up with a cru­cial ap­proval for the ear­ly use of its check­point in­hibitor Keytru­da.

The agency green-light­ed the use of Keytru­da among high ex­pressers of PD-L1, one of the key in­stru­ments that can­cer cells use to de­flect an at­tack by T cells. The FDA had set the PDU­FA date on this sBLA for Christ­mas Eve, but reg­u­la­tors are mov­ing much faster than the nor­mal time­lines per­mit when it comes to the es­tab­lished check­point drugs.

Keytru­da is now the on­ly PD-1 check­point in­hibitor to be ap­proved for front­line use, and pa­tients who qual­i­fy won’t be forced to try chemo first. Mer­ck’s unique sta­tus isn’t a per­ma­nent dis­tinc­tion, though, as Roche con­tin­ues to push ahead with Tecen­triq, a ri­val check­point de­signed specif­i­cal­ly for high PD-L1 ex­pres­sion.

“Keytru­da im­proved sur­vival, com­pared to tra­di­tion­al chemother­a­py, in pa­tients with non-small cell lung can­cer whose tu­mors ex­press high lev­els of PD-L1,” said Roger M. Perl­mut­ter, Mer­ck’s R&D chief, who bet big on Keytru­da’s suc­cess. “The ap­proval of Keytru­da for the first-line treat­ment of metasta­t­ic non-small cell lung can­cer has the po­ten­tial to change the treat­ment land­scape for these pa­tients.”

Bris­tol-My­ers Squibb $BMY stum­bled bad­ly when it tried to beat out chemo as a front­line ther­a­py for NSCLC. The top line da­ta marked a fail­ure, the de­tails on sub­group flops were em­bar­rass­ing. And the sec­ond round of da­ta trig­gered an­oth­er teeter-tot­ter ef­fect on their rel­a­tive stock prices, dri­ving BMS down while Mer­ck con­tin­ued its surge.

Bris­tol-My­ers had dom­i­nat­ed lung can­cer from the get-go, earn­ing the li­on’s share of the first wave of rev­enue that greet­ed these two check­points. Now an­a­lysts say that the ta­bles are be­ing turned, giv­ing Mer­ck an edge that it has des­per­ate­ly sought af­ter.

“We thought Op­di­vo could beat chemother­a­py, and we have an­swered the ques­tion — for the broad pop­u­la­tion it is not enough,” Fouad Namouni, on­col­o­gy de­vel­op­ment head at Bris­tol-My­ers, told David Crow at the Fi­nan­cial Times at ES­MO.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.