Bristol Myers Squibb finally gets in the frontline NSCLC game dominated by Merck, adding a second Opdivo/Yervoy-based option

May 27, 2020 06:36 AM EDTUpdated 07:13 AM

Bristol Myers Squibb finally gets in the frontline NSCLC game dominated by Merck, adding a second Opdivo/Yervoy-based option

Amber Tong

Senior Editor

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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5AM Ventures: Fueling the Next Generation of Innovators

Brian Abrahams

Managing Director and Co-Head of Biotechnology Equity Research

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

January 18, 2021 11:48 AM ESTUpdated January 19, 07:20 AM

Bioregnum

Pssst: That big Biohaven Alzheimer's study? It was a bust. Even the subgroup analysis execs touted was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

January 19, 2021 09:38 AM EST

Regulatory

Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here?

John Carroll

Editor & Founder

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

January 20, 2021 09:48 AM EST

Regulatory

Bristol Myers Squibb gets review date for Opdivo combo in gastric cancer, looking to overturn Keytruda's 3-year lead

Kyle Blankenship

Senior Editor

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.

January 20, 2021 09:31 AM EST

Regulatory

Covid-19 claims another PDUFA victim as GlaxoSmithKline pushes back planned PD-1 rollout

John Carroll

Editor & Founder

Bristol Myers Squibb isn’t the only pharma giant that’s been standing in the FDA’s waiting line for site inspections.

GlaxoSmithKline is telling us today that their H2 2020 PDUFA deadline for the PD-1 drug dostarlimab — picked up in its Tesaro buyout — was pushed back due to a delay in the manufacturing site inspection needed for a regulatory decision. And that is forcing the company to revise its timeline.

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Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

January 20, 2021 09:02 AM EST

Pharma

BioMed Realty snaps up innovation campus site within earshot of pricey and bustling Boston biotech hub

Conner Mitchell

Associate Editor

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.

Cardiovascular chief Joerg Koglin (Merck)

January 20, 2021 07:15 AM ESTUpdated 07:41 AM

Regulatory

Merck makes good on big CV gamble with vericiguat nod — but competition will be fierce

Jason Mast

Editor

The results for Merck’s leading heart drug fell short of what some cardiologists had hoped for, but they proved more than enough to convince the FDA, which handed down an approval Wednesday.

The agency OK’d vericiguat, now marketed as Verquvo, for patients with heart failure, offering one of the first new pharmaceutical tools to tackle a hard-to-treat group of patients at high risk for what remains the leading cause of death in the US and Europe. It’s also a notable win for Merck, who rolled the dice on the molecule in 2016, paying Bayer $1 billion for US rights to the then-experimental drug and ex-US rights for the approved CV drug Adempas.

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Andrew Allen, Gritstone CEO (Gritstone via website)

January 20, 2021 10:40 AM EST

Deals

Coronavirus

Gritstone continues Covid-19 push with deal to develop 'self-amplifying RNA' vaccines, as shares continue ballooning

Max Gelman

Associate Editor

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Hal Barron, GSK R&D chief (GSK via YouTube)

January 20, 2021 08:48 AM ESTUpdated 10:39 AM

R&D

GlaxoSmithKline's $4B bispecific cancer drug alliance with Merck KGaA hit by big setback with a PhIII failure on NSCLC

John Carroll

Editor & Founder

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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