En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months af­ter En­her­tu re­ceived twin break­through ther­a­py des­ig­na­tions, As­traZeneca and Dai­ichi Sankyo are one step clos­er to nab­bing an­oth­er ap­proval for their po­ten­tial block­buster drug.

The com­pa­nies an­nounced Wednes­day morn­ing that their bil­lion-dol­lar an­ti­body-drug con­ju­gate has re­ceived pri­or­i­ty re­view for HER2 pos­i­tive metasta­t­ic gas­tric can­cer. Al­ready ap­proved in the US for third-line metasta­t­ic breast can­cer pa­tients that are HER2 pos­i­tive, En­her­tu’s gas­tric can­cer PDU­FA date is sched­uled for the first quar­ter of 2021.

Wednes­day’s news stems from the pos­i­tive Phase II da­ta that As­traZeneca and Dai­ichi Sankyo pub­lished in NE­JM back in June, the com­pa­nies said. In the 187-per­son tri­al, which ran­dom­ized En­her­tu 2 to 1 against physi­cian’s choice, 51% of the pa­tients in the drug arm re­port­ed an ob­jec­tive re­sponse com­pared to 14% in the con­trol. En­her­tu al­so saw longer over­all sur­vival rates, with a me­di­an of 12.5 months as op­posed to 8.4 months.

An­toine Yver

An­toine Yver, Dai­ichi Sankyo’s glob­al on­col­o­gy chief, not­ed in a state­ment that those re­sults “are un­prece­dent­ed as they rep­re­sent the first time a HER2 di­rect­ed med­i­cine has demon­strat­ed an im­prove­ment in sur­vival fol­low­ing chemother­a­py and HER2 treat­ment in the metasta­t­ic set­tings.”

The pri­or­i­ty re­view is just an­oth­er in a string of suc­cess­ful steps for this part­ner­ship. With­in the span of a week in May, En­her­tu picked up BTDs in both gas­tric can­cer and non-small cell lung can­cer, set­ting up two ad­di­tion­al in­di­ca­tions for the HER2-fight­ing drug. That fol­lowed a rapid ap­proval in breast can­cer last De­cem­ber as the FDA OK came just 8 months af­ter As­traZeneca and Dai­ichi Sankyo signed their col­lab­o­ra­tion agree­ment.

Pas­cal So­ri­ot As­traZeneca

As­traZeneca paid a hefty price at the time, throw­ing close to $7 bil­lion to their part­ners on this drug, in­clud­ing $1.35 bil­lion up­front. The ap­proval came well ahead of sched­ule as well — it had orig­i­nal­ly been sched­uled for some­time in the sec­ond quar­ter of 2020.

En­her­tu now moves even far­ther ahead of a ri­val in Roche’s Kad­cy­la, which flopped 5 years ago in a Phase II/III tri­al in sec­ond-line pa­tients. That tri­al ul­ti­mate­ly proved a rea­son for slow­ing sales of the drug, which once held the $2 bil­lion-plus promise that En­her­tu now holds but has on­ly peaked around $1 bil­lion.

Pas­cal So­ri­ot is like­ly ea­ger to put an­oth­er feath­er in his cap with this deal bear­ing more fruit, as he has through­out his tenure tried to beef up As­traZeneca’s can­cer di­vi­sion through oth­er pro­grams like Imfinzi and Tagris­so. An­a­lysts pre­dict peak sales can sur­pass $2 bil­lion, and Daichii Sankyo has said in the past it ex­pects to reach the $4.5 bil­lion mark.

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

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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.

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.