Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

The OS rate on Op­di­vo fell well short of sta­tis­ti­cal sig­nif­i­cance, with a p val­ue of 0.0752. We’ll have to wait for an up­com­ing sci­ence con­fer­ence to get the full pic­ture.

Bris­tol-My­ers shares $BMY were down 4.5% ahead of the open­ing bell Mon­day as in­vestors re­act­ed to the news that the com­pa­ny is sell­ing Ote­zla to sat­is­fy reg­u­la­tors ahead of its big Cel­gene buy­out.

Re­searchers looked for a sil­ver lin­ing in the lat­est cut of the da­ta onOp­di­vo, say­ing “the re­sults showed a clear trend to­wards im­prove­ment in OS for pa­tients treat­ed with Op­di­vo com­pared to so­rafenib (Nex­avar), a cur­rent stan­dard of care.”

Bruno San­gro Clíni­ca Uni­ver­si­dad de Navar­ra

“We are en­cour­aged by the promis­ing ef­fi­ca­cy and safe­ty trends seen with Op­di­vo in Check­Mate-459, es­pe­cial­ly as HCC is a dev­as­tat­ing and dif­fi­cult-to-treat can­cer, for which there have been no sig­nif­i­cant ad­vances over so­rafenib, a stan­dard treat­ment, in more than a decade,” said Bruno San­gro, head of the liv­er unit, Clíni­ca Uni­ver­si­dad de Navar­ra, Pam­plona, Spain.

But an­a­lysts saw the down­side clear­ly. Vamil Di­van from Cred­it­Su­isse not­ed: “While the tri­al showed a trend to­wards an over­all sur­vival ben­e­fit, the lack of sta­tis­ti­cal sig­nif­i­cance opens the door for com­peti­tors such as Mer­ck, Roche and As­tra to be­come the dom­i­nant play­er(s) in this in­di­ca­tion with the var­i­ous com­bi­na­tion tri­als they are cur­rent­ly run­ning.”

Michael Schmidt at SVB Leerink re­cent­ly not­ed:

In the US, Op­di­vo is gain­ing rapid mar­ket share in 2nd line HCC dri­ven by an ag­gres­sive mar­ket­ing ef­fort by BMY and mas­sive free sam­pling with some off-la­bel use not­ed in front-line pa­tients which is sup­port­ed by strong CM-040 re­sults. In Eu­rope, re­go­rafenib is ex­pect­ed to re­main the pre­ferred 2nd line agent in the near term, giv­en dif­fer­ences in treat­ment pat­tern and pref­er­ences.

Bris­tol-My­ers is by no means fin­ished here, with more re­sults ex­pect­ed on their com­bo with the CT­LA-4 Yer­voy. That match-up, though, has al­ready failed in small cell lung can­cer while in­ves­ti­ga­tors have had to deal with a strong push­back from the FDA in their quest to use high tu­mor mu­ta­tion­al bur­den de­f­i­n­i­tions to de­fine a new ap­proach to iden­ti­fy­ing lung can­cer pa­tients most like­ly to re­spond to Op­di­vo.

Mer­ck, mean­while, has fa­mous­ly pressed ahead in its suc­cess­ful dri­ve to gain the lead po­si­tion in the race to com­mand the PD-1 field. Both Keytru­da and Op­di­vo, though, are ex­pect­ed to re­main the two dom­i­nant drugs in their field for some time.

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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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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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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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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