GlaxoSmithKline punts a key Zejula combo study in ovarian cancer with added setbacks on ICOS and RSV
A chink has appeared in the armor of data that GlaxoSmithKline R&D chief Hal Barron has been building for the PARP inhibitor Zejula.
The pharma giant’s Q2 update on Wednesday includes the note that researchers have ended their Phase II MOONSTONE study, one of a slate of trials that Barron has cited to “help establish Zejula as the most compelling PARP inhibitor for women with ovarian cancer.”
The study had been set up to test the drug plus dostarlimab — its newly approved PD-1 player now sold as Jemperli — among women with platinum-resistant ovarian cancer without a known BRCA mutation. Their preplanned analysis suggested it wouldn’t “meet the high bar” set out in the single-arm study tracking the overall response rate.
That wasn’t the only effort to get the heave-ho today. Their ICOS agonist feladilimab failed the ENTRÉE-Lung sub study 1 at the interim analysis. This lung cancer flop is the third straight failure for this drug in recent months, which has suffered from low expectations after a key setback at Jounce on ICOS. It failed the INDUCE-3 and INDUCE-4 trials for head and neck squamous cell carcinoma.
GSK also noted that “development of phase II RSV paediatric candidate vaccine (viral vector) discontinued following assessment that target efficacy profile was unlikely to be met.”
Barron was an enthusiastic supporter of the deal to acquire Tesaro and Zejula for $5.1 billion in late 2018. He was betting that an insight into the genetics of cancer would make the drug a bigger player than many on Wall Street gave it credit for. And he got dostarlimab, recently approved as the 7th PD-(L)1 to the US market, in the same deal, with some equally muted expectations given its scheduled late arrival.
Zejula sales were £98 million in the quarter, a rising figure, but one that is still considerably off the blockbuster track that would have jazzed analysts.
Barron’s track record at the helm of the R&D group has come under increased scrutiny. Geoffrey Porges in particular has faulted the company’s performance in drug development as shares remain under pressure. And while he’s struck several high-profile deals over the last few months, setbacks in oncology have continued to raise questions about the R&D group’s ability to line up new blockbusters.
CEO Emma Walmsley, meanwhile, took an aggressive stance in today’s quarterly update, bullishly citing a return to more of a business-as-usual stance in key healthcare markets that buoyed earnings. There was also $358 million in adjuvant sales pinned to Covid-19. But GSK’s large vaccine group has largely sat out the Covid crisis, skipping any potential windfalls. And doubts about its long-run performance continue to afflict expectations as activists push for change.