Deciphera's Cancer Drug Improves PFS in GI Stromal Tumors

By Aakash B

August 15, 2019

(Reuters) - In a late-stage study, Deciphera Pharmaceuticals Inc's ripretinib met the main goal of helping patients with advanced gastrointestinal stromal tumors (GIST)live longer without their disease worsening, the company said.

The study tested ripretinib against placebo in 129 patients who had received at least 3 prior therapies.

Median progression-free survival with ripretinib was 6.3 months, compared with a month in case of placebo, the company said, adding that the drug significantly reduced the risk of disease progression or death by 85%.

For the key secondary endpoint of objective response rate, the difference between ripretinib (9.4%) and placebo (0%) was not statistically significant.

Chief Executive Officer Steven Hoerter said the drug's effectiveness and safety profile differentiates it from competition, adding that the data shows potential in the treatment to become best in its class.

The company expects to submit a marketing application for ripretinib to the U.S. Food and Drug Administration in the first quarter of 2020. The treatment was granted 'Fast Track' status in June to treat patients with advanced GIST who have received certain prior treatment.

"The strength of the data is really unprecedented in the space ... and we see this data blowing the competition out of the water," Nomura Instinet analyst Christopher Marai said about the latest trial result.

One potential rival, Blueprint Medicines Corp, submitted an application in June for approval of avapritinib, its treatment for GIST patients, to the U.S. health regulator. The drug is being reviewed as a treatment for GIST patients who have received at least 2 prior therapies.

Marai also said that since ripretinib's trial data is so positive, it is even more likely to benefit patients who have received just one or two prior therapies.

The treatment was in fact well tolerated in an early-stage study testing it in GIST patients who had received at least one prior therapy, the company said.

Separately, Deciphera is also testing the treatment against Pfizer Inc's sunitinib in a late-stage study of GIST patients who have received just one prior therapy. The company expects to enroll 358 patients for the trial with the main goal being progression-free survival, Hoerter said in a conference call with analysts.

Marai expects peak sales for the treatment from the United States and the European Union to be over $1 billion by 2025.