As­traZeneca gets a green light on Imfinzi for small-cell lung can­cer — set­ting the stage for a bat­tle with Roche's Tecen­triq

The stan­dard-of-care for small-cell lung can­cer (SCLC) for decades was plat­inum-based chemother­a­py, but that par­a­digm shift­ed in 2018, with the ap­proval of Bris­tol My­ers Squibb’s check­point in­hibitor Op­di­vo in the sec­ond-line set­ting. Since then, a slate of im­munother­a­pies have se­cured SCLC ap­provals, and the lat­est is As­traZeneca’s flag­ship Imfinzi, which was ap­proved on Mon­day in com­bi­na­tion with stan­dard chemother­a­py as the first line of de­fense in ex­ten­sive-stage SCLC pa­tients.

The ap­proval was based on the re­sults of the late-stage, 805 pa­tient-CASPI­AN tri­al, which test­ed Imfinzi plus stan­dard-of-care chemother­a­py, or Imfinzi and chemother­a­py with the ad­di­tion of As­traZeneca’s in-house CT­LA-4 drug treme­li­mum­ab, ver­sus chemother­a­py alone.

The pri­ma­ry end­point was over­all sur­vival in each of the two ex­per­i­men­tal arms. The com­bi­na­tion of Imfinzi and chemother­a­py cut the risk of death by 27% (HR: 0.73; p=0.0047). Pa­tients on the Imfinzi arm lived a me­di­an 13 months longer, ver­sus 10.3 months in the chemother­a­py group.

The arm with treme­li­mum­ab failed to achieve the pri­ma­ry goal. The Imfinzi/treme­li­mum­ab com­bo, once tout­ed as the cor­ner­stone of As­traZeneca’s check­point de­vel­op­ment strat­e­gy, has al­ready seen a raft of fail­ures in the past — it did not im­prove over­all sur­vival in cer­tain pa­tients with head and neck can­cer, in ad­di­tion to the big flop in the keen­ly-watched MYS­TIC non-small cell lung can­cer (NSCLC) tri­al. Al­though the duo has, when com­bined with chemother­a­py, worked in de­lay­ing dis­ease pro­gres­sion in front­line cas­es of stage 4 NSCLC.

Roche’s Tecen­triq in com­bi­na­tion with chemother­a­py was ap­proved first-line treat­ment for ex­tend­ed stage SCLC last Sep­tem­ber, based on a 30% re­duc­tion in risk of death ob­served in the piv­otal IM­pow­er133 tri­al. Months ear­li­er in June, Mer­ck’s key­stone check­point in­hibitor Keytru­da had scored FDA ap­proval as a monother­a­py for the treat­ment of SCLC pa­tients who had pro­gressed on or af­ter plat­inum-based chemother­a­py and at least one pri­or line of ther­a­py.

On Mon­day, the FDA ap­proved the Imfinzi plus chemother­a­py com­bi­na­tion as a first-line treat­ment for ex­tend­ed-stage SCLC pa­tients, pit­ting against Tecen­triq it in the ex­act same pa­tient pop­u­la­tion.

Mean­while, Phar­ma­Mar’s lur­binecte­din re­ceived pri­or­i­ty re­view last month for the treat­ment of SCLC pa­tients who pro­gressed on plat­inum ther­a­py based on da­ta from a sin­gle-arm, mid-stage study show­ing an over­all re­sponse rate (ORR) of about 35%.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. About two-thirds of SCLC pa­tients are di­ag­nosed with ex­tend­ed stage-SCLC, in which the can­cer has spread wide­ly through the lung or to oth­er parts of the body.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

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

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

Cana­da’s drug price re­forms de­layed to 2021

Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months.

The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process.

Draft pricing guidelines promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been available for stakeholder and public consultation since November 2019. Based on this feedback, the PMPRB will release a final set of revised guidelines the week of 15 June 2020, with a 30-day period of public written consultation to follow.

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.