Mer­ck, Ei­sai notch full ap­proval for Keytru­da-TKI in­hibitor com­bo in ad­vanced en­dome­tri­al can­cer

Mer­ck PD-1 in­hibitor Keytru­da has been in the hot seat as the FDA ri­fles through its ac­cel­er­at­ed ap­proval pro­gram for drugs that even­tu­al­ly flop con­fir­ma­to­ry stud­ies. But for a Keytru­da com­bo with an Ei­sai TKI in­hibitor in en­dome­tri­al can­cer, that won’t be an is­sue.

The FDA on Thurs­day gave its full ap­proval to a com­bi­na­tion of Keytru­da and TKI in­hibitor Lenvi­ma to treat sec­ond-line or lat­er pa­tients with ad­vanced en­dome­tri­al car­ci­no­ma with­out a ge­net­ic mis­match re­pair de­fi­cien­cy or high mi­crosatel­lite in­sta­bil­i­ty, the drug­mak­ers said Thurs­day.

These pa­tients are not el­i­gi­ble for cu­ra­tive surgery or ra­di­a­tion, mak­ing them a dif­fi­cult-to-treat pop­u­la­tion with just a 17% chance of sur­vival af­ter five years, Memo­r­i­al Sloan Ket­ter­ing’s Vicky Makker said in a state­ment.

The agency based its re­view on re­sults from the Phase III KEYNOTE-775/Study 309 tri­al, where the com­bo re­duced the risk of death by 32% com­pared with in­ves­ti­ga­tors’-choice chemother­a­py. Keytru­da-Lenvi­ma al­so hit the co-pri­ma­ry PFS end­point, re­duc­ing the risk of pro­gres­sion or death by 40% with an ob­jec­tive re­sponse rate of 30% and a com­plete re­sponse rate of 5%.

Mer­ck and Ei­sai pre­vi­ous­ly held an ac­cel­er­at­ed ap­proval from the FDA in this in­di­ca­tion, which was grant­ed back in Sep­tem­ber 2019 based on re­sults from the Phase II KEYNOTE-146 study show­ing sig­nif­i­cant tu­moral re­sponse.

It’s a big win for Mer­ck, whose su­per­star I/O drug has been tar­get­ed by the FDA as part of a cleanup ef­fort for drugs that score an ac­cel­er­at­ed ap­proval but lat­er fail their con­fir­ma­to­ry tri­als. Back in April, the FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee pored over six such cas­es, with Keytru­da tak­ing home a split vic­to­ry with the com­mit­tee down­vot­ing its case in third-line stom­ach can­cer and sup­port­ing con­tin­ued ap­provals in he­pa­to­cel­lu­lar car­ci­no­ma and first-line blad­der can­cer.

Ear­li­er this month, Mer­ck fol­lowed up that vote by for­mal­ly with­draw­ing its ac­cel­er­at­ed nod in third-line stom­ach can­cer, mak­ing the first of two no votes dur­ing that ODAC meet­ing to do so. This ac­cel­er­at­ed ap­proval for Keytru­da first came in Sep­tem­ber 2017, but Keytru­da still has three oth­er ac­cel­er­at­ed ap­proval in­di­ca­tions in dif­fer­ent types of stom­ach can­cer, all of which were ap­proved based on tu­mor re­sponse rate and dura­bil­i­ty of re­sponse.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more coverage, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. The total sales numbers indicate that likely about 100 Alzheimer’s patients have so far received the drug, which is priced at $56,000 annually.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.