Gain­ing steam in PD-1/L1 race, Roche re­ports pos­i­tive PhI­II OS da­ta on Tecen­triq com­bo in NSCLC

Roche trot­ted out some ear­ly OS da­ta Mon­day morn­ing from its com­bo study of Tecen­triq in lung can­cer, re­port­ing that the com­bo met its co-pri­ma­ry end­point and helped pa­tients live longer.

The da­ta will back up the com­pa­ny’s up­com­ing bid for ap­proval of the drug com­bo as a front-line ther­a­py, mak­ing Roche a stronger con­tender among ri­vals Bris­tol-My­ers Squibb and Mer­ck as the PD-1/L1 mar­ket leader war wages on.

San­dra Horn­ing

Roche’s close­ly watched Phase III IM­pow­er150 study of a triple com­bo of Tecen­triq, Avastin and chemo showed a sur­vival ben­e­fit “across key sub­groups,” in­clud­ing those with vary­ing lev­els of PD-L1 ex­pres­sion. Genen­tech, a mem­ber of the Roche group, said its com­bo helped pa­tients live “sig­nif­i­cant­ly longer” than those tak­ing Avastin plus car­bo­platin and pa­cli­tax­el.

“We are pleased that the IM­pow­er150 study demon­strat­ed a clin­i­cal­ly mean­ing­ful sur­vival ben­e­fit for peo­ple re­ceiv­ing their ini­tial treat­ment for this type of ad­vanced lung can­cer,” said San­dra Horn­ing, Genen­tech’s CMO and head of glob­al prod­uct de­vel­op­ment, in a state­ment. “These re­sults add to the grow­ing body of ev­i­dence sup­port­ing the role of com­bin­ing Tecen­triq with Avastin. We will sub­mit these ad­di­tion­al da­ta to glob­al health au­thor­i­ties and hope to bring this po­ten­tial treat­ment op­tion to pa­tients as soon as pos­si­ble.”

While the com­bo with Tecen­triq, Avastin, and chemo met its OS co-pri­ma­ry end­point, the com­pa­ny not­ed that leav­ing out Avastin didn’t per­form so well.

At this in­ter­im analy­sis, the study found that sub­sti­tut­ing Avastin with Tecen­triq in the com­bi­na­tion with car­bo­platin and pa­cli­tax­el did not show a sta­tis­ti­cal­ly sig­nif­i­cant OS ben­e­fit in peo­ple with ad­vanced NSCLC com­pared to a com­bi­na­tion of Avastin plus car­bo­platin and pa­cli­tax­el. The study will con­tin­ue as planned to the fi­nal analy­sis.

The new OS da­ta comes af­ter Roche re­port­ed out sol­id PFS da­ta in De­cem­ber. The com­bo 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. 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 al­so re­port­ed out good news just days ago from the same com­bo in squa­mous NSCLC. At an in­ter­im point, that tri­al, called IM­pow­er131, showed the com­bo beat out chemo on PFS with a sta­tis­ti­cal­ly sig­nif­i­cant out­come but had yet to show an over­all sur­vival ben­e­fit.

IM­pow­er150 is one of eight Phase III lung can­cer stud­ies un­der­way at Genen­tech, eval­u­at­ing Tecen­triq alone or in com­bi­na­tion with oth­er med­i­cines. Three more Phase III lung can­cer stud­ies are ex­pect­ed to re­port this year.


Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.