Bris­tol My­ers rolls out 3-year mesothe­lioma da­ta for Op­di­vo/Yer­voy in first look at ES­MO slate

The Op­di­vo/Yer­voy im­munother­a­py com­bo from Bris­tol My­ers Squibb has earned some skep­ti­cism over the years from re­searchers ques­tion­ing the ef­fi­ca­cy of CT­LA-4 in fight­ing tu­mors. But in ad­vanced mesothe­lioma, the com­bi­na­tion is show­ing mul­ti-year clin­i­cal ben­e­fit in a par­tic­u­lar­ly dire pa­tient pop­u­la­tion.

Af­ter a min­i­mum of three years fol­low-up, the Op­di­vo-Yer­voy com­bo con­tin­ued to beat out chemother­a­py in terms of ex­tend­ing the lives of pa­tients with un­re­sectable ma­lig­nant mesothe­lioma as a first-line ther­a­py, ac­cord­ing to up­dat­ed da­ta from the CHECK­MATE-743 study set to be pre­sent­ed Fri­day at the ES­MO vir­tu­al con­fer­ence.

Twen­ty-three per­cent of pa­tients treat­ed with the com­bo were alive at the three-year mark com­pared with 15% on chemo, Bris­tol My­ers said. Mean­while, Op­di­vo/Yer­voy con­tin­ued to show a re­duc­tion in risk of death with a me­di­an OS of 18.1 months com­pared with 14.1 months for chemo.

Mean­while, the com­bo con­tin­ued to show durable re­spons­es un­der­scor­ing those OS re­sults. At three years, 28% of re­spon­ders pre­vi­ous­ly treat­ed with Op­di­vo-Yer­voy but off ther­a­py for one year re­mained in re­sponse com­pared with 0% on chemo. Over­all, the com­bo post­ed a me­di­an du­ra­tion of re­sponse of 11.6 months com­pared with 6.7 months for chemo and an ob­jec­tive re­sponse rate that was “com­pa­ra­ble” to chemo — 39.6% to 44%, re­spec­tive­ly.

Solange Pe­ters

“For pa­tients with ma­lig­nant pleur­al mesothe­lioma, the prog­no­sis is gen­er­al­ly poor, with a five-year sur­vival rate of ap­prox­i­mate­ly 10%,” said Solange Pe­ters, an on­col­o­gist at the Lau­sanne Uni­ver­si­ty Hos­pi­tal in Switzer­land, in a state­ment. “In this ag­gres­sive can­cer that his­tor­i­cal­ly has had lim­it­ed treat­ment op­tions, we’ve now not on­ly seen the po­ten­tial for pa­tients to live longer with (Op­di­vo) plus (Yer­voy), but that this ben­e­fit is sus­tained at three years com­pared to treat­ment with chemother­a­py. These re­sults give us fur­ther proof of the dura­bil­i­ty of the out­comes achieved with this com­bi­na­tion.”

The Op­di­vo/Yer­voy com­bo is now ap­proved in 14 reg­u­la­to­ry zones for this in­di­ca­tion, where it re­ceived an ini­tial FDA ap­proval in Oc­to­ber. The im­munother­a­py reg­i­men was the first new sys­temic ther­a­py ap­proved to treat un­re­sectable ma­lig­nant mesothe­lioma since 2004.

The fol­low-on da­ta is the first look at Bris­tol My­ers’ planned slate at this year’s ES­MO, which starts on Fri­day. In ad­di­tion to the CHECK­MATE-743 da­ta, the drug­mak­er is rolling out more sur­vival da­ta for the Op­di­vo-Yer­voy com­bo in oth­er in­di­ca­tions and an up­date on in­ves­ti­ga­tion­al LAG-3 in­hibitor re­latlimab’s piv­otal study. There’s al­so a planned late-break­er from the Op­di­vo-Yer­voy com­bo in CHECK­MATE-649 in first-line gas­tric can­cer.

Stay tuned this week for more.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Ash Shehata, KPMG

As sup­ply chain wor­ries ease up, Big Phar­ma CEOs have a new top con­cern: re­cruit­ing and keep­ing em­ploy­ees

As the industry goes through a boom, Big Pharma’s CEOs seem to have realized one thing above the rest: It’s time to reward the people doing the leg work.

KPMG, a Big Four accounting network, has compiled a business confidence report for pharma CEOs for the past few years, and while 2020’s report had top executives soul-searching for answers and predictions amidst a chaotic time, it appears that some normalcy, coupled with the skyrocketing growth of the industry, has restored confidence levels at the top.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Kevin Boyle, Ziopharm Oncology CEO

Zio­pharm lays off half its staff af­ter man­u­fac­tur­ing is­sues force de­lays

New Ziopharm CEO Kevin Boyle has only been at the biotech for less than a month, but he’s already engineering major changes.

Late Monday afternoon, Ziopharm announced a sweeping restructuring that involved eliminating more than half its workforce and 60 jobs in total. The layoffs were necessary to help the penny stock player refocus its attention on advancing its TCR program, which saw a setback earlier this year after “unforeseen delays” at a contract manufacturer, Ziopharm said.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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