As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

An­oth­er day, an­oth­er win for En­her­tu.

The an­ti­body-drug con­ju­gate As­traZeneca promised up-to $7 bil­lion to part­ner on has had a quite a few months, be­gin­ning with splashy re­sults in a Phase II breast can­cer tri­al, a rapid ap­proval and, ear­li­er this month, break­through des­ig­na­tions in both non-small cell lung can­cer and gas­tric can­cer.

Ko­hei Shi­tara

Now, at AS­CO, the British phar­ma and their Japan­ese part­ner, Dai­ichi Sankyo, have shown off the da­ta that led to the gas­tric can­cer des­ig­na­tion, which they’ll take back to the FDA. In a piv­otal, 187-per­son Phase II tri­al, En­her­tu shrunk tu­mors in 42.9% of third-line pa­tients with HER2-pos­i­tive stom­ach can­cer, com­pared with 12.5% in a con­trol arm where doc­tors pre­scribed their choice of ther­a­py. Pro­gres­sion-free sur­vival was 5.4 months for En­her­tu com­pared to 3.5 months for the con­trol.

Most cru­cial­ly, the drug proved more ef­fec­tive in ex­tend­ing pa­tients’ lives; the me­di­an over­all sur­vival was 12.5 months for En­her­tu, com­pared to 8.4 months in the con­trol.

“Once pa­tients with HER2-pos­i­tive metasta­t­ic gas­tric can­cer progress fol­low­ing ini­tial treat­ment with an an­ti-HER2 reg­i­men, there are lim­it­ed op­tions and no ap­proved HER2-tar­get­ed ther­a­pies,” lead in­ves­ti­ga­tor Ko­hei Shi­tara said in a state­ment. “Based on the com­pelling re­sults of the DES­TINY-Gas­tric01 tri­al, En­her­tu has the po­ten­tial to be­come a new stan­dard of care for these pa­tients.”

Pas­cal So­ri­ot As­traZeneca

The pos­i­tive re­sults are par­tic­u­lar­ly note­wor­thy be­cause a key ri­val drug failed against gas­tric can­cer. Kad­cy­la, Roche’s block­buster HER2 tar­get­ing an­ti­body drug con­ju­gate, flopped 5 years ago in a Phase II/III tri­al in sec­ond-line pa­tients. That tri­al was part of what damp­ened sales for the drug, which once held the $2 bil­lion-plus promise that En­her­tu now holds but has ul­ti­mate­ly peaked around $1 bil­lion.

The da­ta add to what has quick­ly emerged as a suc­cess­ful AS­CO for As­traZeneca and CEO Pas­cal So­ri­ot, who has spent much of his near­ly decade-long tenure rein­vent­ing the ail­ing British Phar­ma’s can­cer R&D en­gine. Last night, they re­leased much-an­tic­i­pat­ed da­ta from their Tagris­so non-small cell lung can­cer tri­al, show­ing that af­ter 2 years of fol­low up, 90% of pa­tients were tu­mor-free. They were not able, though, to yet show a sur­vival ben­e­fit.

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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Ed Kaye, Stoke Therapeutics CEO

Stoke touts ear­ly signs of ef­fi­ca­cy for Dravet syn­drome drug

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.