As gener­ic com­pe­ti­tion stut­ter sales of top on­col­o­gy drugs, Roche se­cures speedy re­view for pair of ex­per­i­men­tal can­cer of­fer­ings

As drug de­vel­op­ers seek ways to ex­pand ther­a­peu­tic ap­pli­ca­tions and over­come the hur­dles seen with the first gen­er­a­tion of an­ti­body drug con­ju­gates (AD­Cs), Roche is cap­i­tal­iz­ing on its tro­jan horse ADC — pow­ered by Seat­tle Ge­net­ics’ tech­nol­o­gy — as gener­ics eat in­to the sales of its tri­fec­ta of top can­cer drugs. On Tues­day, the Swiss drug­mak­er said its an­ti-CD79b ADC — po­latuzum­ab ve­dotin — had won the FDA’s pri­or­i­ty re­view for use in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL), a field that is with­in the clutch of CAR-T ther­a­pies.

The FDA is ex­pect­ed to make its de­ci­sion by Au­gust 19, Roche said on Tues­day.

Po­latuzum­ab ve­dotin is be­ing re­viewed by the reg­u­la­tor when added to ben­damus­tine and Rit­ux­an (BR). The triplet had pre­vi­ous­ly se­cured break­through ther­a­py sta­tus. The pri­or­i­ty re­view was grant­ed on the ba­sis of an 80-pa­tient study in heav­i­ly pre-treat­ed sub­jects that showed the com­bo eclipsed me­di­an over­all sur­vival (an ex­plorato­ry end­point) com­pared to BR alone, help­ing pa­tients live longer by 12.4 months ver­sus 4.7 months. Da­ta al­so showed 40% of peo­ple treat­ed with po­latuzum­ab ve­dotin plus BR achieved a com­plete re­sponse (CR), while on­ly 18% of peo­ple treat­ed with BR alone achieved a CR.

The CD79b pro­tein is ex­pressed in the ma­jor­i­ty of types of B-cell non-Hodgkin lym­phomas, the most com­mon sub­type of NHL. Al­though pa­tients are gen­er­al­ly re­spon­sive to first­line treat­ment, as many as 40% of pa­tients re­lapse, af­ter which op­tions are lim­it­ed and sur­vival is short. Po­latuzum­ab ve­dotin, which is be­ing test­ed for use in sev­er­al types of NHL, binds to CD79b and dec­i­mates B-cells via a tar­get­ed ap­proach: min­i­miz­ing the ef­fects on healthy cells while max­i­miz­ing tu­mour cell death, us­ing ADC tech that is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Sep­a­rate­ly, Roche has al­so won a pri­or­i­ty re­view for en­trec­tinib, a drug for use in neu­rotroph­ic tropomyosin re­cep­tor ki­nase (NTRK) fu­sion-pos­i­tive, lo­cal­ly ad­vanced or metasta­t­ic sol­id tu­mors in pa­tients whose can­cer has pro­gressed de­spite ther­a­py as well as pa­tients with metasta­t­ic ROS-1 pos­i­tive non-small cell lung can­cer (NSCLC).

The FDA is ex­pect­ed to make its de­ci­sion on the drug, which has pre­vi­ous­ly se­cured break­through ther­a­py sta­tus, by Au­gust 18, Roche said.

Roche, which bagged en­trec­tinib late in 2017 with its $1.7 bil­lion Igny­ta buy­out, hopes the drug will fare well ver­sus Bay­er’s Vi­t­rakvi — the first drug ap­proved by the FDA for NTRK fu­sion can­cers and the run­ner up ’tis­sue ag­nos­tic’ can­cer treat­ment that won the US reg­u­la­to­ry nod. With­in NSCLC, en­trec­tinib will be up against Pfiz­er’s Xalko­ri, which is the stan­dard treat­ment in ROS-1 pos­i­tive pa­tients.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

Endpoints Premium

Premium subscription required

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

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.

The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.