Roche pulls dan­gling ac­cel­er­at­ed ap­proval for Tecen­triq in triple-neg­a­tive breast can­cer

Roche on Fri­day de­cid­ed to vol­un­tar­i­ly pull an in­di­ca­tion won via the FDA’s ac­cel­er­at­ed ap­proval path­way for its block­buster PD-L1 drug Tecen­triq.

This is the third ac­cel­er­at­ed ap­proval to be pulled fol­low­ing an ODAC meet­ing last April to re­view six in­di­ca­tions from Roche, Mer­ck and Bris­tol My­ers Squibb block­buster can­cer drugs, where con­fir­ma­to­ry tri­als failed. This is al­so the fourth ac­cel­er­at­ed ap­proval to be pulled in the last month.

The move to pull Tecen­triq in com­bi­na­tion with chemo for the treat­ment of adults with un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer comes af­ter the FDA’s on­co­log­ic drugs ad­comm vot­ed 7-2 to keep it dan­gling, while oth­er, ad­di­tion­al con­fir­ma­to­ry tri­als were on­go­ing.

But Roche said it came to its de­ci­sion af­ter re­cent con­ver­sa­tions with FDA on an­oth­er post­mar­ket­ing tri­al, and “due to the re­cent changes in the treat­ment land­scape,” which the com­pa­ny said means that the FDA “no longer con­sid­ers it ap­pro­pri­ate to main­tain the ac­cel­er­at­ed ap­proval.”

With lim­it­ed oth­er treat­ment op­tions at the time, Tecen­triq ini­tial­ly won its ac­cel­er­at­ed OK in com­bi­na­tion with nab-pa­cli­tax­el for adult pa­tients with mTNBC whose tu­mors ex­press PD-L1 in March 2019, based on a me­di­an pro­gres­sion-free sur­vival of 7.4 months, which com­pared with 4.8 months for those on place­bo in com­bo with nab-pa­cli­tax­el.

But the con­fir­ma­to­ry tri­al did not pan out and even showed a wor­ri­some sign as the place­bo out­per­formed the treat­ment com­bo in terms of over­all sur­vival.

Laleh Amiri-Ko­rdestani, di­vi­sion di­rec­tor at the Of­fice of On­co­log­ic Dis­eases, pre­sent­ed for the FDA at the ODAC meet­ing and not­ed the over­all sur­vival re­sults in the ini­tial tri­al (on which the ac­cel­er­at­ed ap­proval was based) may have been due to chance alone, and that the ben­e­fit seen in the first tri­al was not cor­rob­o­rat­ed in a sim­i­lar pop­u­la­tion in the con­fir­ma­to­ry tri­al.

Roche em­pha­sized that Fri­day’s de­ci­sion on­ly im­pacts the mTNBC in­di­ca­tion in the US and does not af­fect oth­er ap­proved in­di­ca­tions for Tecen­triq in the US and out­side the US. In 2020, Tecen­triq brought in al­most $3 bil­lion in world­wide sales.

Al­so fol­low­ing that high-stakes April ODAC meet­ing, Mer­ck last month agreed to pull a third-line stom­ach can­cer in­di­ca­tion for its block­buster Keytru­da, which re­ceived a thumbs down from ODAC af­ter late-stage con­fir­ma­to­ry tri­als failed to show clin­i­cal ben­e­fit. And Bris­tol My­ers late last month al­so pulled an in­di­ca­tion re­viewed by ODAC for Op­di­vo as a monother­a­py for he­pa­to­cel­lu­lar car­ci­no­ma pa­tients who have pre­vi­ous­ly been treat­ed with so­rafenib.

Over­all, the out­side ex­perts vot­ed to rec­om­mend pulling two of the six in­di­ca­tions re­viewed, both of which have now been pulled, in ad­di­tion to Roche’s de­ci­sion. It re­mains un­known what may come for the oth­er two in­di­ca­tions re­viewed at the meet­ing.

Sep­a­rate­ly, Bris­tol My­ers in ear­ly Au­gust al­so pulled an Is­to­dax in­di­ca­tion in pe­riph­er­al T cell lym­phoma af­ter a Phase III con­fir­ma­to­ry study for the drug flopped on its pro­gres­sion-free sur­vival end­point.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

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.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.