#ESMO18: Crowned with a breakthrough title, Clovis takes an early lead as it races for a fast OK for Rubraca in prostate cancer

MUNICH — With Lynparza from AstraZeneca and Merck expanding on a big lead for ovarian and breast cancer, Clovis Oncology $CLVS is mapping a separate route in prostate cancer for their PARP rival Rubraca that may pay off handsomely.

The Boulder, CO-based biotech turned up in Munich today to unveil an early look at Phase II data from their TRITON2 study, with a 44% confirmed objective response rate in 25 second-line, RECIST-evaluable patients with a BRCA1/2 alteration. Researchers also claimed a 51% PSA response rate in 45 prostate cancer patients as well as some biomarker reactions that they count as a promising sign for the future data to come out of the program.

We already knew that the data would be upbeat at ESMO. Clovis won a breakthrough drug designation from the FDA for the castration-resistant crowd of patients based on the early mid-stage results. 

That move encouraged Andrew Berens at Leerink to offer a cheer at the time:

We see BTD as encouraging for the company ahead of the presentation of Phase 2 data at ESMO on 10/21, and continue to believe that prostate cancer expansion could add a unique dimension to the Clovis story.

If the data hold up, Clovis could be on track to winning the first, accelerated approval in prostate cancer, with a pitch coming by the end of 2019. Berens estimates that an approval there would be worth $580 million in peak sales for that indication alone.

That’s an upbeat assessment for a company that has had to deal with an SEC investigation into the way they handled their roci data. You’ll note that Clovis restricted itself to confirmed ORRs for Rubraca’s prostate cancer data after being accused of playing fast and loose with the roci results, misleading their investors at the time.

Later over the weekend we’ll find out the hard data that AstraZeneca nailed down for Lynparza in frontline maintenance ovarian cancer, which they have already hailed as promising. These PARP inhibitors interfere with DNA repair mechanisms, killing targeted, fast growing cancer cells. 

It’s a crowded field, especially now that Pfizer just won an OK for its PARP, the fourth on the US market, with Tesaro also in the mix. These PARPs, though, have proven to be quite similar, so a first-to-market success may provide only a temporary win, with tolerability offering one way for a leader to distinguish itself.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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