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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Roche un­veils three new mon­key­pox tests as cas­es rise

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.