GSK/Tesaro PARP in­hibitor Ze­ju­la wins an­oth­er speedy re­view

Months af­ter part­ner Zai Lab $ZLAB scored an ac­cel­er­at­ed re­view for PARP ther­a­py Ze­ju­la in Chi­na, GSK has se­cured pri­or­i­ty US re­view for the drug, known chem­i­cal­ly as ni­ra­parib, to ex­pand the use of the drug in pa­tients with ad­vanced ovar­i­an can­cer.

GSK $GSK, which shelled out just over $5 bil­lion to swal­low Ze­ju­la-de­vel­op­er Tesaro, said the FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24.

The drug was sub­mit­ted for re­view in pa­tients with ad­vanced ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer pa­tients with or with­out BR­CA mu­ta­tions who have been treat­ed with three or more pri­or chemother­a­py reg­i­mens based on da­ta from the QUADRA tri­al, which showed 13 (28%) of 47 pa­tients in the pri­ma­ry ef­fi­ca­cy pop­u­la­tion achieved an over­all re­sponse — the best re­sponse record­ed from the start of the treat­ment un­til the dis­ease pro­gress­es — as per RE­CIST (Re­sponse Eval­u­a­tion Cri­te­ria in Sol­id Tu­mors) method­ol­o­gy.

Mary Lynne Hed­ley

“The re­sults of the QUADRA study demon­strate that ZE­JU­LA is ac­tive as a late-line treat­ment for pa­tients be­yond those with BR­CA mu­ta­tions,” said Tesaro’s COO Mary Lynne Hed­ley in a state­ment.

Ovar­i­an can­cer is the most com­mon cause of gy­nae­co­log­i­cal can­cer death in the Unit­ed States. Al­though most pa­tients with ad­vanced ovar­i­an can­cer re­spond to ini­tial ther­a­py, 70% will re­lapse and ul­ti­mate­ly suc­cumb to their dis­ease. Late-line treat­ment op­tions for pa­tients with ovar­i­an can­cer are few, with the pro­por­tion of pa­tients achiev­ing an over­all re­sponse typ­i­cal­ly less than 10%, and me­di­an over­all sur­vival af­ter third-line ther­a­py of 5–9 months, re­searchers not­ed in Lancet On­col­o­gy.

The drug, which com­petes against As­traZeneca’s $AZN Lyn­parza as well as Clo­vis’ $CLVS Rubra­ca, is al­ready ap­proved as a first­line main­te­nance treat­ment of women with re­cur­rent ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer when their can­cer comes back.

The once-dai­ly Ze­ju­la is cur­rent­ly be­ing eval­u­at­ed in three piv­otal tri­als, in­clud­ing a late-stage tri­al in pa­tients with first-line ovar­i­an can­cer (the PRI­MA tri­al), a Phase III tri­al for the treat­ment of pa­tients with germline BR­CA-mu­tat­ed, metasta­t­ic breast can­cer (the BRA­VO tri­al), and a reg­is­tra­tional Phase II treat­ment tri­al in pa­tients with ovar­i­an can­cer (the QUADRA tri­al). Part­ner J&J $JNJ is test­ing the use of the drug in prostate can­cer. Mean­while, a num­ber of com­bi­na­tion tri­als are al­so un­der­way, in­clud­ing test­ing the use of Ze­ju­la and Mer­ck’s $MRK key­stone check­point in­hibitor Keytru­da in breast and ovar­i­an can­cer.

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.

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.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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