Roche's triplet in­volv­ing Tecen­triq clears the PFS bar for melanoma when added to BRAF/MEK com­bo

In a “check the box” ex­er­cise, Roche said it has shown that adding Tecen­triq to a com­bo of Cotel­lic and Zelb­o­raf was ef­fec­tive in ex­tend­ing pro­gres­sion-free sur­vival in melanoma pa­tients com­pared to place­bo plus the two drugs.

Pa­tients with pre­vi­ous­ly un­treat­ed BRAF V600 mu­ta­tions were re­cruit­ed to the Phase III study, dubbed IM­spire150.

Levi Gar­raway

Cotel­lic (which was ini­tial­ly de­vel­oped by Roche part­ner Ex­elix­is) and Zelb­o­raf are al­ready ap­proved to treat BRAF V600E or V600K mu­ta­tion-pos­i­tive un­re­sectable or metasta­t­ic melanoma. While the lat­ter blocks some BRAF ki­nas­es, the for­mer is be­lieved to help break treat­ment re­sis­tance by al­so in­hibit­ing MEK1/2.

Some­times, though, that’s still not enough, thus the at­tempts to add a third agent to in­crease the dura­bil­i­ty of treat­ment — ei­ther a tar­get­ed ther­a­py or, in this case, an im­munother­a­py.

Roche has tried to test a com­bo of Tecen­triq plus just Cotel­lic for treat­ment-naive cas­es, but that com­bi­na­tion failed to beat stan­dard-of-care Keytru­da in a sep­a­rate tri­al, IM­spire170, un­veiled ear­li­er this year.

The phar­ma gi­ant record­ed around $44 mil­lion in Cotel­lic sales in the first three quar­ters of 2019, while Tecen­triq fetched over $1.3 bil­lion.

Cotel­lic and Zelb­o­raf had two heavy­weight ri­vals in No­var­tis, which mar­kets Mekin­ist and Tafin­lar, as well as Pfiz­er af­ter it snapped up Ar­ray and its Mek­tovi/Braftovi pair­ing. All play­ers are look­ing to go be­yond melanoma now — Pfiz­er is es­pe­cial­ly keen about the prospects in col­orec­tal can­cer — though Roche has suf­fered some set­backs.

Stifel an­a­lyst Stephen Wil­ley has pre­vi­ous­ly de­scribed the triplet vs dou­blet com­par­i­son as more of a “check the box” than “ex­pand the mar­ket” move.

The next step will be to check the reg­u­la­to­ry box.

“By com­bin­ing a can­cer im­munother­a­py with tar­get­ed ther­a­pies, we hope to of­fer a new ap­proach that im­proves out­comes for peo­ple with ad­vanced, BRAF-mu­tant melanoma,” CMO Levi Gar­raway said in a state­ment.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

Jeff Albers, Blueprint CEO

Blue­print Med­i­cines nabs 4th ap­proval in bid to­ward prof­itabil­i­ty

Blueprint Medicines’ push to profitability continues.

On Wednesday, the Cambridge biotech announced the FDA approved its longtime lead drug, Ayvakit, for advanced systemic mastocytosis, a group of debilitating rare diseases where one type of immune cell — mast cells — builds up uncontrollably in a particular organ. The decision came on the heels of Phase III trials showing that more than half of late-stage patients who received the drug responded to it and did so for just over three years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.