Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling be­hind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecen­triq with a grow­ing ex­per­tise in lung can­cer. The drug will now take an ear­ly lead in the sought-af­ter ad­ju­vant set­ting — but com­peti­tors are on the way.

The FDA on Fri­day ap­proved Tecen­triq as an ad­ju­vant ther­a­py for pa­tients with Stage II-II­IA non small cell lung can­cer with PD-(L)1 scores greater than or equal to 1, mak­ing it the first drug of its kind ap­proved in an ear­ly set­ting that cov­ers around 40% of all NSCLC pa­tients.

The agency based its re­view on da­ta from the Phase III IM­pow­er010 study, which showed ad­ju­vant Tecen­triq cut the risk of re­lapse or death by 34% over best sup­port­ive care. Tecen­triq was placed on pri­or­i­ty re­view from the agency in this in­di­ca­tion back in ear­ly Au­gust, mak­ing it a speedy turn­around from the FDA.

Tecen­triq’s win here could spell block­buster sales, with some an­a­lysts pre­dict­ing a mar­ket op­por­tu­ni­ty of more than $1 bil­lion for the drug. The ap­proval could al­so be the first of many in ear­ly NSCLC, one of the largest can­cer in­di­ca­tions in the US, where Tecen­triq has carved out a niche de­spite stiff com­pe­ti­tion from some of the best sell­ing drugs in the world.

Ad­ju­vant/neoad­ju­vant im­munother­a­py care has emerged as a new fron­tier in the fight be­tween the PD-(L)1s with Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo tak­ing home wins of their own across oth­er tu­mor types. Both drug­mak­ers have hopes in NSCLC as well, with Mer­ck look­ing at Keytru­da as part of the Phase I MK3475-223 study for ad­ju­vant Stage I-II NSCLC.

Mean­while, Bris­tol My­ers is much fur­ther along in its Phase III CHECK­MATE-816, test­ing a com­bi­na­tion of Op­di­vo and chemother­a­py as a neoad­ju­vant — be­fore surgery — ther­a­py for Stage II-III NSCLC.

The drug read out topline da­ta from one of the study’s pri­ma­ry end­points in April show­ing the com­bo post­ed a 24% patho­log­i­cal com­plete re­sponse rate for pa­tients across the PD-(L)1 ex­pres­sion spec­trum com­pared with just 2.2% for chemo alone. The drug­mak­er is wait­ing out re­sults on event-free sur­vival, the study’s sec­ond ma­jor end­point, which could set up a fil­ing close af­ter.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.