Hal Barron's team at GSK scores a win with positive Zejula PhIII frontline study — now comes the hard part
Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.
The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.
GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.
That field of also-rans also includes Clovis and Pfizer.
Skeptics scolded GSK for the acquisition, but Barron remained constant to the notion that ongoing trials like this one would wedge open a much larger market opportunity. And doing it with an already approved cancer drug that would set the stage for more additions out of the oncology pipeline.
Monday morning Barron underscored that notion in a prepared remark, saying:
Almost 300,000 women around the world are diagnosed with ovarian cancer every year, yet only about 15% of patients are currently eligible to receive PARP inhibitors as their initial therapy. These exciting data demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer.
We won’t get the hard data until later in the year, but you can expect that the regulatory team has been preparing for this since GSK completed the buyout.
There’s more to come. CEO Emma Walmsley highlighted the ovarian cancer play during the buyout, noting additional work for breast cancer and non-small cell lung cancer. Hal Barron has also noted:
Our understanding of ovarian cancer is growing all the time and we know now that the BRCA mutations are not the only mutations that cause this DNA repair problem. In fact, clinical trials are under way to assess the use of Zejula in ovarian cancer patients with what is known as homologous recombination defects (HRD). These are the patients who we believe have a BRCA-like tumor and could benefit from treatment with Zejula.
Barron’s team won an accelerated review for that just a couple of weeks ago, setting the stage for a unique indication that could be worth considerably more to GSK. The PDUFA date is October 24.
Having convinced a group of analysts that GSK had made the wrong move in its quest to reignite enthusiasm for the company’s pipeline, though, trying to whip up excitement now is going to be a hard sell. Skeptics will want to see the hard cash. And that’s GSK’s next challenge on the commercial side.