Mer­ck’s PhI­II liv­er can­cer study for Keytru­da fails on two key end­points, just three months af­ter the FDA gave it the green light

In a rare set­back, Mer­ck has suf­fered a key Phase III fail­ure for Keytru­da that could put a crimp in its sales prospects.

Roy Baynes

The phar­ma gi­ant re­port­ed af­ter the mar­ket closed on Tues­day that Keytru­da failed the KEYNOTE-240 study for he­pa­to­cel­lu­lar car­ci­no­ma, the most com­mon type of liv­er can­cer. The tri­al missed on both over­all sur­vival as well as pro­gres­sion-free sur­vival. That news ar­rived just 3 months af­ter the FDA of­fered an ac­cel­er­at­ed ap­proval on liv­er can­cer based on their ear­li­er mid-stage da­ta for the drug. 

Stay­ing on the mar­ket re­quires Mer­ck to put up pos­i­tive piv­otal da­ta. Ques­tions about the drug’s fu­ture in liv­er can­cer dinged Mer­ck’s stock $MRK, which dropped slight­ly more than 1% af­ter the re­lease hit.

Mer­ck was quick to note that it’s study­ing Keytru­da in a range of oth­er liv­er can­cer stud­ies, but the ad­van­tage here has clear­ly switched to Op­di­vo for now, which has been drag­ging steadi­ly be­hind Keytru­da af­ter falling short on lung can­cer, where Mer­ck holds first-line ad­van­tage.

This wasn’t the on­ly con­fir­ma­to­ry Phase III study to flop. Just weeks ago Eli Lil­ly had to sus­pend mar­ket­ing of Lartru­vo af­ter its piv­otal for soft tis­sue sar­co­ma failed. These back-to-back set­backs, though, are un­like­ly to slow down the FDA, which has proved ea­ger to hand out ac­cel­er­at­ed OKs — par­tic­u­lar­ly for can­cer drugs — in re­cent years.

“While we are dis­ap­point­ed KEYNOTE-240 did not meet its co-pri­ma­ry end­points, the re­sults for over­all sur­vival, pro­gres­sion-free sur­vival and ob­jec­tive re­sponse rate are gen­er­al­ly con­sis­tent with find­ings from the Phase II study, KEYNOTE-224, which led to the ac­cel­er­at­ed ap­proval of KEYTRU­DA for the treat­ment of pa­tients with he­pa­to­cel­lu­lar car­ci­no­ma who have been pre­vi­ous­ly treat­ed with so­rafenib,” said Roy Baynes, se­nior vice pres­i­dent and head of glob­al clin­i­cal de­vel­op­ment, chief med­ical of­fi­cer, Mer­ck Re­search Lab­o­ra­to­ries.


Pho­to cred­it: AP Im­ages.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

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The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

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As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Chi­nese rare dis­ease play­er inks first deal around nar­colep­sy drug Wak­ix af­ter grab­bing $80M to build an ecosys­tem

Two months ago, the narcolepsy therapy Wakix propelled Harmony Biosciences to a $128 million debut on Nasdaq. Now, the same drug is serving as the foundation for a Chinese biotech looking to pioneer a rare disease platform in the country.

Citrine Medicine — which closed $80 million in Series A funding in July — was incubated by F-Prime and Eight Roads, two VC funds affiliated with Fidelity Investments that saw an opening in China to replicate in the vibrant orphan drug landscape in the US (and to a lesser extent, Europe).

Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

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Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

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Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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