Op­di­vo/Yer­voy com­bo flops again in melanoma, but Bris­tol My­ers Squibb al­so has a new OK to cel­e­brate

Bris­tol My­ers Squibb’s Op­di­vo/Yer­voy com­bo reg­i­men has of­fi­cial­ly failed both co-pri­ma­ry end­points in a tri­al test­ing it as an ad­ju­vant ther­a­py for melanoma.

Adding Yer­voy, the CT­LA4 in­hibitor, to the PD-1 an­ti­body Op­di­vo failed to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in re­cur­rence-free sur­vival among the all-com­er pop­u­la­tion, the phar­ma gi­ant re­port­ed. The news comes al­most one year af­ter Bris­tol My­ers con­ced­ed that the pair­ing didn’t help pa­tients with very low lev­els of PD-L1 — who would the­o­ret­i­cal­ly be less like­ly to ben­e­fit from Op­di­vo — any more than the Op­di­vo alone did.

The set­back high­lights the rocky path Bris­tol My­ers has been on ex­plor­ing the dual im­munother­a­py ap­proach, which ex­ecs hoped could of­fer a chemo-free al­ter­na­tive in dif­fer­ent types of can­cers.

Re­sults had been mixed. On the same day the lat­est Check­Mate-915 read­out was re­leased, the FDA OK’d Op­di­vo plus Yer­voy for the first-line treat­ment of pa­tients with ma­lig­nant pleur­al mesothe­lioma that can­not be re­moved by surgery — mark­ing the first new drug for the tu­mor, which is usu­al­ly found in the lung’s lin­ings, in 16 years.

The on­ly oth­er ther­a­py was ap­proved in 2004, FDA on­col­o­gy czar Richard Paz­dur not­ed, and it was peme­trexed in com­bi­na­tion with cis­platin.

Reg­u­la­tors based the OK on an open-la­bel tri­al pit­ting Op­di­vo and Yer­voy against chemother­a­py. The Bris­tol My­ers drugs helped pa­tients live a me­di­an of 18.1 months ver­sus 14.1 months on chemo.

Num­bers weren’t avail­able for Check­Mate-915, but the com­pa­ny man­aged to find a sil­ver lin­ing, not­ing that it “re­in­forced the es­tab­lished ben­e­fit of Op­di­vo monother­a­py as a stan­dard of care in the ad­ju­vant set­ting.”

“We de­signed this study to de­ter­mine if dual im­munother­a­py has the po­ten­tial to bring ad­di­tion­al ben­e­fits to pa­tients in this set­ting, un­der­stand­ing the high bench­mark we would need to ex­ceed with this tri­al,” Sabine Maier, head of on­col­o­gy de­vel­op­ment, said in a state­ment.

Next steps in­clude a com­plete eval­u­a­tion of the full da­ta, which will be pre­sent­ed at an up­com­ing con­fer­ence.

She added that Bris­tol My­ers will con­tin­ue to ex­plore the com­bo among high-risk melanoma pa­tients in ear­li­er stages of dis­ease. Check­Mate-915 fo­cused on pa­tients with stage II­Ib/c/d or stage IV melanoma who have had their tu­mors com­plete­ly re­moved by surgery.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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