October 27, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Following an unexpected setback of Bristol-Myers Squibb ’s Opdivo as a monotherapy for a “broad patient population” in patients with untreated advanced non-small cell lung cancer, the company plans to undergo a reorganization of its research and development unit.
Although what the reorganization will fully mean is unknown, as BMS provided a bare outline of its plans in its third-quarter announcement this morning. In its announcement, the company said the reorganization includes the implementation of a “more agile R&D organization” and “streamlined operations and realigned manufacturing capabilities that broaden biologics capabilities to reflect current and future portfolio.”
“The new operating model will enable the company to deliver the strategic, financial and operational flexibility necessary to invest in the highest priorities across the company,” BMS said in its statement.’
Giovanni Caforio, chief executive officer of BMS, said in a statement that despite the setback of Opdivo, which he termed as short-term, the company’s overall strategic focus has not changed.
“Going forward, we see growth in both the near and long term to continue to be driven by Opdivo, Eliquis and Orencia, and by an exciting pipeline of specialty medicines over time. As we focus on the future, we are evolving our operating model to more effectively focus resources on key priorities and simplify execution to deliver sustainable growth and to speed transformational medicines to patients,” Caforio said in a statement.
The announcement came two months after BMS’ lead PD-1 inhibitor Opdivo failed to meet its endpoints of progression-free survival in patients expressing PD-L1 at 5 percent in a Phase III trial. That setback for Opdivo gave rival Merck the window it needed for its own PD-1 inhibitor, Keytruda, to grab some market share. In data released Oct. 9 during a meeting of the European Society for Medical Oncology, Merck announced patients who took Keytruda, a PD-1 Inhibitor, lived 40 percent longer than those on chemo. According to the data Keytruda extended life for about 10.3 months from the start of treatment, while patients on chemo lived for about six months. Overall, 66 percent of patients with metastatic NSCLC expressed any level of PD-L1, and 28 percent expressed high levels of PD-L1. Additionally, about 45 percent of patients on Keytruda saw shrinkage in their tumors, compared to the 28 percent who were undergoing chemo, Merck said earlier this month. Merck is looking for the U.S. Food and Drug Administration to rule on Keytruda as a first-line treatment for lung cancer by Christmas. Keytruda has already been approved for lung cancer patients whose cancer got worse after chemotherapy.
Opdivo has an advantage over Keytruda, which requires patients pass a regulatory diagnostic before being prescribed the medication. BMS’ treatment does not have that restriction, which may make it preferable to prescribe. Additionally, Opdivo’s failed Phase III trial had a much larger patient population than the Keytruda trial. The Keytruda data was from a patient population expressing 50 percent PD-1 and not 5 percent, as the Opdivo trial was.
Left out of this morning’s announcement from BMS was how the company plans to make the R&D group “more agile.” The company has been striking deals with other companies to develop immuno-oncology treatments, including its most recent deal with Bay Area’s Nektar Therapeutics . Under that deal the companies will explore immunotherapy treatments for five different tumor types by combining its blockbuster immuno-therapy Opdivo with Nektar’s investigational medicine, NKTR-214.
Opdivo, which is being heavily advertised in the media, had sales near $1 billion in 2015, but analysts predict it could go much, much higher, hitting nearly $13 billion annually within a few years.
