In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they se­cured the first FDA ap­proval for a check­point ther­a­py in triple-neg­a­tive breast can­cer, a no­to­ri­ous­ly dif­fi­cult-to-treat in­di­ca­tion that has been passed over by the wave of tar­get­ed ther­a­pies.

Now, though, doc­tors are puz­zling over why a com­bi­na­tion of drugs meant to make that ther­a­py more po­tent in­stead ap­peared to make it less ef­fec­tive.

Roche said Thurs­day that in a Phase III tri­al, com­bin­ing their PD-1/L1 check­point ther­a­py Tecen­triq with the chemother­a­py pa­cli­tax­el, did not sig­nif­i­cant­ly im­prove pro­gres­sion-free sur­vival for pa­tients with lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer over giv­ing those pa­tients chemother­a­py alone. In fact, pa­tients on the Tecen­triq-chemo arm had low­er over­all sur­vival than pa­tients on chemo, al­though the drug­mak­er cau­tioned that the tri­al was not pow­ered for that end­point and the da­ta were im­ma­ture.

The fail­ure is a set­back for triple-neg­a­tive breast can­cer pa­tients who, de­spite new med­i­cines such as Im­munomedics’ an­ti­body-drug con­ju­gate Trodelvy, con­tin­ue to face worse odds and few­er treat­ment op­tions than oth­er breast can­cer pa­tients.

It is al­so a set­back for Roche. Trail­ing Mer­ck and Bris­tol My­ers Squibb in the check­point space, and with As­traZeneca as­cen­dant, the Swiss phar­ma had hoped to carve a strong niche in triple-neg­a­tive breast can­cer.

Re­searchers have long com­bined chemother­a­py with new­er drugs such as check­point in­hibitors and tar­get­ed agents, so some were sur­prised that the com­bo would have lit­tle ef­fect. A few doc­tors de­bat­ed it on Twit­ter, with Sherene Loi of the Pe­ter Mac Can­cer Cen­tre in Aus­tralia of­fer­ing that the fail­ure may have been a prod­uct of the chemother­a­py and a steroid pa­tients re­ceived be­fore treat­ment: By low­er­ing white blood cell counts, it could have in­ter­fered with the ef­fects of the im­munother­a­py.

Levi Gar­raway

In a state­ment, Levi Gar­raway, CMO of Roche’s big biotech sub Genen­tech, hint­ed at a sim­i­lar hy­poth­e­sis, say­ing that re­searchers need to bet­ter un­der­stand how can­cer, the im­mune sys­tem, and the dif­fer­ent ther­a­pies doc­tors throw at them all in­ter­act.

“To­day’s re­sults un­der­score the need to bet­ter un­der­stand the can­cer and im­mune sys­tem in­ter­ac­tions, in­clud­ing the chemother­a­py back­bone and as­so­ci­at­ed reg­i­mens,” he said.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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With KRAS break­through on the hori­zon, Am­gen's David Reese re­flects on so­tora­si­b's loom­ing re­view date and murky fu­ture

After decades of failures laid waste to R&D outfits looking to solve the KRAS G12C puzzle, Amgen is as close as anyone ever has been to an approval with sotorasib. For Amgen R&D head David Reese, the drug’s looming review date is a point of reflection for his own career and a big milestone for Amgen’s blooming — if controversial — next-gen oncology pipeline.

Amgen filed its FDA application for sotorasib in December to treat metastatic non-small cell lung cancer with the KRAS mutation — once thought to be “undruggable” — months after the agency offered its breakthrough designation based on pivotal Phase I data showing previously unheard of response rates.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.

Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.