#AS­CO21: As­traZeneca's PD-L1 Imfinzi tacks on 5-year sur­vival da­ta in NSCLC, which it's call­ing 'un­prece­dent­ed'

Amid a sea of com­peti­tors in PD-(L)1, As­traZeneca has looked to out­run the big dogs in Mer­ck and Bris­tol My­ers Squibb with its Imfinzi. One way to dif­fer­en­ti­ate? Long-term ef­fect — and now As­traZeneca has five-year da­ta in NSCLC it thinks can set its drug apart.

David Spigel

Imfinzi post­ed an over­all sur­vival rate of 43% for Stage III non-small cell lung can­cer pa­tients whose tu­mors can’t be re­moved five years af­ter chemora­di­a­tion treat­ment, ac­cord­ing to da­ta from the Phase III PA­CIF­IC study set to be re­leased at this week­end’s #AS­CO21.

The OS rate for pa­tients who re­ceived Imfinzi was 10% high­er than those who re­ceived place­bo. His­tor­i­cal­ly, just be­tween 15% and 30% of pa­tients in this group sur­vive for 5 years af­ter treat­ment, but the 43% mark is no­table progress, Sarah Can­non Re­search In­sti­tute CSO David Spigel said in a press re­lease.

Mean­while, the pro­gres­sion-free sur­vival rate for pa­tients was 33% com­pared with 19% in the place­bo group, As­traZeneca said.

“More­over, three quar­ters of these pa­tients had al­so not pro­gressed in that time,” Spigel said. “This is a mo­men­tous achieve­ment at the five-year land­mark in this cu­ra­tive-in­tent set­ting.”

Lung can­cer is re­spon­si­ble for 1 in 5 can­cer deaths, As­traZeneca said. Be­tween 80 and 85% of lung can­cer pa­tients have NSCLC, and a quar­ter of those pa­tients are di­ag­nosed at Stage III, which the ma­jor­i­ty of tu­mors can­not be re­moved with surgery. For pa­tients in the PA­CIF­IC Phase III tri­al, Imfinzi is the first new treat­ment avail­able to pa­tients.

The PA­CIF­IC tri­al was con­duct­ed at 235 lo­ca­tions in 26 coun­tries and in­volved 713 pa­tients. Imfinzi is be­ing test­ed in sev­er­al dif­fer­ent stud­ies. Sci­en­tists hope that it could be used as a treat­ment for pa­tients with he­pa­to­cel­lu­lar car­ci­no­ma, bil­iary tract can­cer (which is a form of liv­er can­cer), cer­vi­cal can­cer and ovar­i­an can­cer, among oth­ers. As a part of its im­munother­a­py port­fo­lio, As­traZeneca is work­ing to­ward de­vel­op­ing ap­proach­es that can use Imfinzi as a sin­gle treat­ment across a broad range of tu­mors.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

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

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

Endpoints Premium

Premium subscription required

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

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

Endpoints Premium

Premium subscription required

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