Look­ing for a come-from-be­hind win, Roche touts its piv­otal suc­cess for Tecen­triq com­bo in front-line lung can­cer

Trail­ing far be­hind Mer­ck $MRK and Bris­tol-My­ers Squibb $BMY, the lead­ers in the heat­ed show­down for mar­ket su­prema­cy in the PD-1/L1 com­mer­cial race, Roche is mak­ing its move in the key lung can­cer mar­ket with a set of promis­ing, pro­gres­sion-free sur­vival da­ta for a com­bi­na­tion us­ing Tecen­triq.

Their close­ly watched Phase III IM­pow­er150 study of a triple com­bo of Tecen­triq, Avastin and chemo demon­strat­ed a dou­bling in 12-month pro­gres­sion-free sur­vival rates among a broad group of front­line lung can­cer pa­tients, set­ting the stage for a quick reg­u­la­to­ry OK on both sides of the At­lantic.

“We have a re­al chance to be at the fore­front here,” Roche CEO Sev­erin Schwan told Reuters ahead of the da­ta re­lease. “Our am­bi­tion is to be­come a clear leader in the field of can­cer im­munother­a­pies.”

Com­par­ing the triple against Avastin and chemo alone, re­searchers tracked a 38% re­duc­tion in the risk of dis­ease pro­gres­sion, with the pro­gres­sion-free sur­vival rate hit­ting 8.3 months for the triple against 6.8 months for the dou­ble. The haz­ard ra­tio (HR) was 0.62. In a sub­group of peo­ple de­fined by a bio­mark­er (T-ef­fec­tor “Teff” gene sig­na­ture ex­pres­sion Teff WT), the PFS hit an im­pres­sive 11.3 months for the triple.

Roche’s bot­tom line:

Im­por­tant­ly, a dou­bling of the 12-month land­mark PFS rate was ob­served with the com­bi­na­tion of Tecen­triq and Avastin plus chemother­a­py (37 per­cent) com­pared to Avastin plus chemother­a­py (18 per­cent). The rate of tu­mor shrink­age (over­all re­sponse rate, ORR), a sec­ondary end­point in the study, was high­er in peo­ple treat­ed with Tecen­triq and Avastin plus chemother­a­py com­pared with Avastin plus chemother­a­py (64 per­cent vs. 48 per­cent).

“Dou­bling PFS (pro­gres­sion-free sur­vival) at one year is some­thing we have not seen with any tar­get­ed ther­a­py in un­s­e­lect­ed pa­tients to date,” Solange Pe­ters, the head of Med­ical On­col­o­gy at the Cen­tre Hos­pi­tal­ier Uni­ver­si­taire Vau­dois in Lau­sanne, told the wire ser­vice.

San­dra Horn­ing

Not every­one was ready to call the play as en­tire­ly in Roche’s fa­vor, though. Ever­cor­eISI’s Uber Raf­fat rushed to Mer­ck’s de­fense this morn­ing. And Leerink’s Sea­mus Fer­nan­dez sees Mer­ck re­main­ing in the lead for lung can­cer.

On the neu­tral to neg­a­tive side, the ben­e­fit ap­pears to be dri­ven large­ly by bio­mark­er pos­i­tive pa­tients – al­low­ing for a wide range of ques­tions in­clud­ing com­par­isons to MRK’s Keytru­da as monother­a­py in PDL1 high pa­tients. How­ev­er, the unique ben­e­fit of Tecen­triq + Avastin in EGFR/ALK mu­ta­tion pos­i­tive pa­tients may se­cure a place for this com­bi­na­tion in 15-20% of pa­tients glob­al­ly as a sec­ond or third line treat­ment op­tion.

Roche faces a big chal­lenge on the check­point front. Top ex­ecs be­lieve that Tecen­triq is key to the com­pa­ny’s abil­i­ty to re­place rev­enue lost as its big three fran­chise drugs see gener­ic com­pe­ti­tion build up and carve away rev­enue. But the phar­ma gi­ant has al­so had its own set­backs with their PD-L1 ther­a­py, with a sting­ing fail­ure on blad­der can­cer that spurred fresh de­bate over the rel­a­tive val­ue of a PD-1 ver­sus a PD-L1.

To­day, they suc­cess­ful­ly coun­tered that dis­cus­sion, though this de­bate is far from over.

“This Tecen­triq study is the first pos­i­tive Phase III com­bi­na­tion tri­al that showed a can­cer im­munother­a­py re­duced the risk of the dis­ease get­ting worse when used as an ini­tial treat­ment in a broad group of peo­ple with ad­vanced non-squa­mous NSCLC,” said San­dra Horn­ing, Roche’s chief med­ical of­fi­cer. “The IM­pow­er150 study rep­re­sents an im­por­tant ad­vance in lung can­cer treat­ment, and we will sub­mit these re­sults to reg­u­la­to­ry au­thor­i­ties around the world to po­ten­tial­ly bring a new stan­dard of care to peo­ple liv­ing with this dis­ease as soon as pos­si­ble.”

Im­age: Roche CEO Sev­erin Schwan Ap Im­ages

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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