Mer­ck halts prostate can­cer study while re­port­ing pos­i­tive read­out in bil­iary tract can­cer

Mer­ck is slam­ming the brakes on a late-stage Keytru­da study in prostate can­cer af­ter an in­ter­im analy­sis showed no im­prove­ment in sur­vival, the com­pa­ny an­nounced on Wednes­day. How­ev­er, the phar­ma gi­ant cush­ioned the blow with a pos­i­tive look at a sep­a­rate study in bil­iary tract can­cer.

An in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee re­view­ing the Phase III KEYNOTE-991 tri­al saw no im­prove­ment in over­all sur­vival or ra­di­ograph­ic pro­gres­sion-free sur­vival in a Keytru­da com­bi­na­tion group com­pared to the con­trol group, Mer­ck said in a news re­lease. The tri­al was con­duct­ed in more than 1,200 pa­tients with metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC), or those whose can­cer is con­trolled by keep­ing testos­terone lev­els as low as would be ex­pect­ed af­ter cas­tra­tion.

Re­searchers paired Keytru­da with en­za­lu­tamide, sold by Astel­las and Pfiz­er un­der the brand name Xtan­di, and an­dro­gen de­pri­va­tion ther­a­py (ADT), while con­trol pa­tients re­ceived a place­bo in com­bi­na­tion with en­za­lu­tamide and ADT. The study wasn’t slat­ed for com­ple­tion un­til 2026, ac­cord­ing to a fed­er­al reg­is­ter of clin­i­cal tri­als.

In ad­di­tion to fail­ing the pri­ma­ry end­points, the Keytru­da com­bo group ex­pe­ri­enced a greater amount of se­ri­ous ad­verse events, ac­cord­ing to the news re­lease.

“Mer­ck is in­form­ing study in­ves­ti­ga­tors of the de­ci­sion and ad­vis­es pa­tients in the study to speak to their physi­cian re­gard­ing treat­ment,” the com­pa­ny said.

The news comes on the heels of Keytru­da’s late-stage fail in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) back in Au­gust. More than 1,000 pa­tients with mCR­PC who did not re­spond to hor­mone ther­a­py en­rolled in the tri­al, dubbed KEYNOTE-921. How­ev­er, Keytru­da along­side chemother­a­py failed to best chemother­a­py alone in both over­all and pro­gres­sion-free sur­vival.

Sci­en­tists con­tin­ue to test Keytru­da in a hand­ful of stud­ies for mCR­PC pa­tients, Mer­ck said on Wednes­day.

Mean­while, the Big Phar­ma un­veiled some pos­i­tive re­sults from a fi­nal analy­sis of its KEYNOTE-966 tri­al in ad­vanced or un­re­sectable bil­iary tract can­cer (BTC), lin­ing up a ri­val­ry with As­traZeneca’s Imfinzi.

Eli­av Barr

First-line pa­tients who took Keytru­da along with stan­dard-of-care chemother­a­py saw a sta­tis­ti­cal­ly sig­nif­i­cant change in over­all sur­vival com­pared to those who took on­ly chemo, ac­cord­ing to Mer­ck. While the com­pa­ny has yet to show the hard num­bers, Mer­ck Re­search Lab­o­ra­to­ries’ se­nior VP, head of clin­i­cal de­vel­op­ment and CMO Eli­av Barr said in a news re­lease that the com­pa­ny is “very en­cour­aged” by the re­sults.

“Bil­iary tract can­cer is typ­i­cal­ly di­ag­nosed at an ad­vanced stage, and these pa­tients face a poor prog­no­sis, with five-year sur­vival rates es­ti­mat­ed to be ap­prox­i­mate­ly 5% to 15%,” he said.

As­traZeneca’s PD-L1 block­buster Imfinzi beat Keytru­da across the fin­ish line in this set­ting, claim­ing a win for ad­vanced BTC pa­tients back in Sep­tem­ber. The ri­val drug is in­di­cat­ed along­side the chemother­a­py drugs gem­c­itabine and cis­platin. An es­ti­mat­ed 25% of pa­tients treat­ed with Imfinzi plus chemo in a Phase III tri­al were still alive at two years, ver­sus 10% treat­ed with chemother­a­py alone, ac­cord­ing to As­traZeneca.

Mer­ck’s stock $MRK was up by less than 1% on Wednes­day, trad­ing at around $109.41 per share.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

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Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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