[ad_1]
MUNICH-Pfizer's Ibrance may have narrowly failed to show it could help relapsed breast cancer patients live longer. But execs contend its recent results still make a "compelling" case.
In a phase 3 study dubbed Paloma-3, HR-positive, HER2-negative breast cancer patients in the Ibrance-plus-fulvestrant arm lived a median 34.9 months-nearly seven months longer than the median 28 months recorded in the fulvestrant-only group , Pfizer said at the European Society for Medical Oncology annual meeting. But that difference comes from the statistical significance mark.
RELATED: In rare slip, Pfizer steamroller Ibrance fails to show it helps patients live longer
Pfizer Oncology Global President Andy Schmeltz was made of the most important aspects of the trial, which focused on the endocrine therapy.
"The primary endpoint, progression-free survival … it's been a while ago, and that's what the study has been for," he said.
He also pointed to the "stringent statistical criteria for significance," noting that Ibrance "just barely missed."
"Particularly in breast cancer, more than other types of cancer, it is challenging to demonstrate overall survival because of the race of the disease. It's a slower than other types of tumors, "meaning that doctors can put patients on other therapies after the Ibrance regimen, confounding the measurement of overall survival.
The way he sees it, "showing the best of the best conditions for metastatic breast cancer is this combination."
Plenty of doctors are likely to agree. The Ibrance-fulvestrant como picked up its FDA approval back in February 2016, and it's racked up nods in more than 80 countries around the world. All told, 160,000 women have been treated with Ibrance since it first hit the market, Schmeltz said.
RELATED: A slowing market-not new rivals-is hurting Pfizer's star drug cancer Ibrance, executives say
Still, a fair share of patients do not receive the blockbuster, and that's what Pfizer's hoping the new data can help change. For doctors "who are not quite there," the new results provide "yet further evidence" of Ibrance's utility, he said.
Meanwhile, Pfizer is already looking forward to the next frontier for Ibrance, which is facing relatively new challengers in Eli Lilly 's Verzenio and Novartis' Kisqali. The company is testing Ibrance in early breast cancer, and it expects to see those studies.
Earlier Ibrance "could even prevent and delay metastasis, which would be a game-changer for breast cancer," Schmeltz said, adding, "we're excited for the future."
Source link
