Pfizer’s Ibrance has met with immense success in metastatic breast cancer since breaking onto the scene in 2015. But its first foray into early breast cancer was a bust, the company reported late Friday.
Adding the drug to standard post-surgery endocrine therapy was unlikely to significantly lengthen patients’ time before invasive disease returned, an independent data monitoring committee determined after a planned futility analysis of the phase 3 Pallas trial, which studied Ibrance in women and men with HR-positive, HER2-negative early breast cancer.
RELATED: Pfizer's fast-growing Ibrance romps toward an early $5B payoff: analyst
The result was “a surprise and disappointment,” as RBC Capital Markets analyst Randall Stanicky put it in a note to clients, and investors agreed, sending Pfizer shares down by about 7% in after-market trading. The company has for years been talking up Ibrance’s potential to move earlier into therapy and unlock a big new commercial opportunity; back in 2017, Morgan Stanley analyst David Risinger pegged the adjuvant opportunity at $8 billion-plus.
In the wake of the failure, though, investors will have to pin their hopes on another trial—dubbed Penelope-B—testing the drug in patients with a high risk of recurrence after pre-surgery chemo. That study, which began enrolling patients about two years earlier than Pallas, is still ongoing, Stanicky noted, adding that “in theory, we would expect more events to have occurred in the higher-risk patient subgroup,” indicating that trial may be going better.
Those results will be along later this year, but while they might ease the sting of the Pallas flop, they won’t erase it completely. The high-risk group represents “a smaller commercial opportunity” relative to the Pallas population, Stanicky pointed out.
RELATED: The top 20 drugs by 2018 U.S. sales - Ibrance
Ibrance currently bears a U.S. approval, when coupled with an aromatase inhibitor, to treat postmenopausal women or men with HR-positive, HER2-negative metastatic breast cancer who haven’t yet received other hormone therapy. Paired with fulvestrant, it’s cleared to treat patients whose disease has progressed after hormone therapy.
Thanks to those indications, the drug racked up $3.25 billion in U.S. sales last year, despite in-class competition from Novartis’ Kisqali and Eli Lilly’s Verzenio. Worldwide, Ibrance’s 2019 sales hit $4.96 billion.
"breast" - Google News
May 31, 2020 at 04:41AM
https://ift.tt/2ySGt04
Pfizer's Ibrance misses shot at big new market with early breast cancer failure - FiercePharma
"breast" - Google News
https://ift.tt/2ImtPYC
https://ift.tt/2Wle22m
Bagikan Berita Ini
0 Response to "Pfizer's Ibrance misses shot at big new market with early breast cancer failure - FiercePharma"
Post a Comment