Giovanni Caforio, AP Images

Bris­tol My­ers Squibb takes an­oth­er late-stage loss for Op­di­vo-Yer­voy com­bo in head and neck can­cer

Bris­tol My­ers Squibb has worked over­time to hunt down an edge for its PD-(L)1 block­er Op­di­vo over ri­val Keytru­da from Mer­ck, in­clud­ing tak­ing a bold com­bo strat­e­gy with CT­LA4 in­hibitor Yer­voy. But in head and neck can­cer, the com­bo keeps drop­ping duds.

Op­di­vo plus Yer­voy failed to show clin­i­cal ben­e­fit in ex­tend­ing the lives of first-line pa­tients with re­cur­rent or metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck, ac­cord­ing to topline re­sults from the Phase III CHECK­MATE-651 study re­vealed Fri­day.

The tri­al test­ed the duo against what’s known as the EX­TREME reg­i­men, a first-line com­bo of Er­bitux, cis­platin/car­bo­platin and flu­o­rouracil, the drug­mak­er said.

Bris­tol My­ers took a shot at spin­ning a pos­i­tive, say­ing the study da­ta showed a “clear, pos­i­tive trend to­wards over­all sur­vival” for high ex­press­ing PD-L1 pos­i­tive pa­tients and not­ing the study’s con­trol arm per­formed “bet­ter than ex­pect­ed based on his­tor­i­cal da­ta.”

But it’s a fail­ure, nonethe­less, and a missed op­por­tu­ni­ty to gain ground on Keytru­da. In a state­ment, Ab­der­rahim Oukessou, Bris­tol My­ers’ VP of tho­racic can­cers and de­vel­op­ment lead, called the re­sults “dis­ap­point­ing.”

As of now, full re­sults aren’t avail­able, and Bris­tol My­ers said it would con­duct a “full eval­u­a­tion” be­fore al­low­ing the sci­en­tif­ic com­mu­ni­ty to as­sess the dam­age.

The topline re­sults aren’t all that sur­pris­ing giv­en Op­di­vo-Yer­voy al­ready flopped a head-to-head study against Op­di­vo alone in these same pa­tients back in 2019, the first sign the com­bi­na­tion could be in for some tur­bu­lence. The com­bo does hold a sec­ond-line ap­proval in this in­di­ca­tion dat­ing back to 2016 based on a pos­i­tive OS read­out in the CHECK­MATE-141 tri­al.

Op­di­vo, which sports an ap­proval in the first-line set­ting dat­ing back to 2016, could al­so be in trou­ble in head and neck can­cer af­ter drug price watch­dog the Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE) telegraphed in Jan­u­ary that it had stopped rec­om­mend­ing the so­lo check­point in­hibitor’s use on Eng­land’s NHS.

The drug had pre­vi­ous­ly been avail­able as part of NICE’s Can­cer Drug Fund, which al­lows physi­cians to ap­ply for use on a case-by-case ba­sis, but in­ves­ti­ga­tors found the drug’s clin­i­cal ben­e­fit pro­file wasn’t stur­dy enough to even en­dorse lim­it­ed use.

Mean­while, Keytru­da al­so sports an ap­proval in that same in­di­ca­tion dat­ing to rough­ly the same time, but has faced less of an up­hill climb. Part of the rea­son is Mer­ck hasn’t chased a com­bo ap­proval along­side a CT­LA4 block­er like Yer­voy. The drug­mak­er has been adamant that not all can­cers ben­e­fit from the PD-1/CT­LA4 com­bi­na­tion, ef­fec­tive­ly throw­ing cold wa­ter on Bris­tol My­ers’ pipeline strat­e­gy.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.

Tib­so­vo clears an­oth­er hur­dle for Servi­er, but can it make Agios' old drug prof­itable?

When European regulators saw the data Agios used to win US approval for their AML drug Tibsovo, they sent the more than decade-old biotech back to the drawing board. A single, single-armed trial was not going to cut it.

On Monday, though, the drug’s new owners announced it had cleared a more rigorous study. In a randomized, Phase III trial of certain newly diagnosed patients, those who received a combination of Tibsovo and chemotherapy lived longer than those who received a combination of placebo and chemotherapy. Those patients also had higher response rates and complete remission rates.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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How the bio­phar­ma in­dus­try is help­ing to pay for the bi­par­ti­san in­fra­struc­ture bill

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.