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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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