In a stun­ner, Mer­ck leaps ahead of ri­vals with com­bo Keytru­da/chemo at­tack on lung can­cer

Mer­ck’s im­muno-on­col­o­gy team has be­come ex­pert at press­ing an ear­ly ad­van­tage.

The Keytru­da com­pa­ny, which re­cent­ly trounced Bris­tol-My­ers in their ri­val­ry on lung can­cer, has now filed an ear­ly and stun­ning ap­pli­ca­tion to mar­ket a com­bi­na­tion of Keytru­da and chemo for first-line lung can­cer. And the move has the po­ten­tial to carve out a short­cut that will al­low them to cut ahead of a strug­gling As­traZeneca and a po­tent Roche.

Mer­ck’s stock $MRK spiked close to 5% on the news of its lat­est ad­vance in the field as an­a­lysts pon­dered the im­pli­ca­tions in a field with block­buster po­ten­tial. Check­points alone treat on­ly a por­tion of all can­cer pa­tients, and a front­line com­bo could cap­ture the li­on’s share of the mar­ket.

The FDA ac­cept­ed the sup­ple­men­tal ap­pli­ca­tion and agreed to give the ap­pli­ca­tion a speedy re­view, of­fer­ing a de­ci­sion by May 10. And giv­en the agency’s go-go record on rush­ing ahead on promis­ing I/O ther­a­pies, Mer­ck may be on the verge of mak­ing an even ear­li­er break­through with its first com­bo ap­proach.

As­traZeneca ear­li­er re­tooled its im­muno-on­col­o­gy ef­fort for dur­val­um­ab, its all-im­por­tant check­point pro­gram, as it lagged be­hind the fron­trun­ners in the field. It’s now lin­ing up for the fourth or pos­si­bly fifth new ap­proval for a check­point, as it looks to en­ter a crowd­ed mar­ket in­volv­ing some of the most ag­gres­sive play­ers in the in­dus­try. And af­ter mul­ti­ple set­backs over the past year, the UK gi­ant can ill af­ford to con­tin­ue get­ting beat in I/O if it ever ex­pects to de­liv­er on am­bi­tious fore­casts of rev­enue growth.

As­traZeneca’s stock dropped 1% on the news.

Mer­ck’s play here is not with­out risk. Sea­mus Fer­nan­dez at Leerink not­ed:

MRK’s an­nounce­ment of the ac­cep­tance of an sBLA fil­ing for Keytru­da (pem­brolizum­ab) + chemother­a­py in first-line (1L) non-squa­mous non-small cell lung can­cer (NSCLC) re­gard­less of PD-L1 sta­tus comes as a sig­nif­i­cant sur­prise, po­ten­tial­ly es­tab­lish­ing Keytru­da as the first IO agent to be used broad­ly in non-squa­mous NSCLC re­gard­less of PDL1 sta­tus. FDA’s will­ing­ness to ac­cept the fil­ing based on such a small study (with no ev­i­dence of a sur­vival ben­e­fit in the da­ta pre­sent­ed at ES­MO) sug­gests to us that the agency may have vis­i­bil­i­ty in­to the like­li­hood of suc­cess on the PFS end­point in the on­go­ing Phase 3 Keynote-189 tri­al. If this com­bo re­ceives ac­cel­er­at­ed ap­proval by its PDU­FA date of 5/10/17, it like­ly would give MRK an­oth­er leg-up in the 1L NSCLC race over AZN (OP) and BMY’s (OP) IO+IO com­bos and RHH­BY’s (NR) IO+chemo com­bo. While we con­tin­ue to be­lieve that IO+IO com­bos will even­tu­al­ly pro­duce more durable re­spons­es (par­tic­u­lar­ly in pa­tients with high­er lev­els of PD-L1 ex­pres­sion), an ear­ly and broad ac­cel­er­at­ed ap­proval for this IO+chemo com­bo could fur­ther es­tab­lish Keytru­da as the PD-1 of choice in the 1L set­ting – at least un­til oth­er agents are ap­proved in this set­ting.

Roger Dansey, Mer­ck

Mer­ck has mount­ed hun­dreds of stud­ies around its Keytru­da fran­chise, of­ten part­ner­ing on po­ten­tial com­bos as the team mar­ries an im­mune sys­tem at­tack with com­ple­men­tary ther­a­pies.

Bris­tol-My­ers has al­so been la­bor­ing long and hard with Op­di­vo. But it’s ear­ly lead in the field was bad­ly dam­aged in 2016 as an over­ly am­bi­tious at­tempt to grab proof of ef­fi­ca­cy as a stand­alone lung can­cer drug end­ed in dis­as­ter.

Dr. Roger Dansey, se­nior vice pres­i­dent and ther­a­peu­tic area head, on­col­o­gy late-stage de­vel­op­ment, Mer­ck Re­search Lab­o­ra­to­ries, has this to say:

“Keytru­da in com­bi­na­tion with chemother­a­py has shown promise ver­sus chemother­a­py alone in the first-line treat­ment of non-squa­mous metasta­t­ic non-small cell lung can­cer, re­gard­less of PD-L1 lev­els. If ap­proved, this could be the first reg­i­men com­bin­ing chemother­a­py with an im­muno-on­col­o­gy agent for pa­tients with ad­vanced non-small cell lung can­cer.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.