BMS Flying High in May With Opdivo, Zeposia FDA Approvals
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Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look.
Zeposia for Ulcerative Colitis
The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb Company’s Zeposia (ozanimod) for adults with moderately to severely active ulcerative colitis (UC). The FDA approved Zeposia in 2020 for adults with relapsing forms of multiple sclerosis (RMS), and the company plans to market it for UC under the same name.
The drug is an oral sphingosine 1-phosphate (S1P) receptor modulator that binds to S1P receptors 1 and 5 with high affinity. It decreases the ability of lymphocytes to migrate from lymphoid tissue and cuts the number of circulating lymphocytes in peripheral blood. However, it’s not known precisely how the drug works for clinical effects in UC, although they believe it involves the reduction of lymphocyte migration into the intestines.
The approval was based on data from the Phase III True North study of Zeposia in UC patients who had an inadequate response or were intolerant to a range of other therapies, including oral aminosalicylates, corticosteroids, immunomodulators, or a biologic.
“Despite the availability of approved therapies, there is still unmet need and an opportunity to deliver additional treatment options to help patients better manage their disease,” said Adam Lenkowsky, general manager and head, U.S., Cardiovascular, Immunology and Oncology, BMS.
“We’re thrilled that our pursuit of transformative science in immunology may benefit patients in their ulcerative colitis treatment by introducing a new option that has a different mechanism of action than available therapies. Zeposia combines disease control through lasting remission and demonstrated safety in a once-daily pill.”
Opdivo as Adjuvant for Esophageal or Gastroesophageal Junction Cancer
On May 20, the FDA approved BMS’s Opdivo (nivolumab) for adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval was built on data from the Phase III CheckMate -577 trial.
In the study, patients who received Opdivo experienced disease-free survival (DFS) for twice as long as those in the placebo cohort and decreased the risk of disease recurrence or death by 31% compared to placebo. Opdivo is a checkpoint inhibitor.
“Today’s news marks an important step for patients as well as meaningful progress toward our commitment to pioneering immunotherapy treatment options in earlier stages of the disease where there is the potential to reduce the risk of recurrence,” said Lenkowsky at the time.
BMS’ LAG-3-Blocking Antibody and Opdivo Combination Effective in Melanoma
On May 19, BMS announced data from the Phase II/III RELATIVITY-047 trial of relatlimab and Opdivo (nivolumab) together compared to Opdivo alone in patients with previously untreated metastatic or unresectable melanoma.
The trial demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) compared to Opdivo alone. In patients receiving the combo, the median PFS was 10.12 months compared to 4.63 months in the Opdivo cohort.
“LAG-3 represents a new immunotherapy target and the results of the RELATIVITY-047 study demonstrated the significant benefit of inhibiting both LAG-3 and PD-1 with the novel combination of relatlimab and involumab,” said F. Stephen Hodi, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute. “With the observed efficacy and safety profile, the combination with relatlimab may provide an important new treatment option for patients with metastatic melanoma.”
BMS Partners with Agenus on Cancer Therapy
On May 18, BMS agreed to pay Agenus up to $1.56 billion to develop and commercialize AGEN1777. The drug is mainly being evaluated to improve anti-tumor activity and will be tested with BMS’s immuno-oncology drugs in non-small cell lung cancer, which makes up about 85% of lung cancer cases worldwide.
BMS is paying Agenus $1.36 billion in development, regulatory and commercial milestones, as well as double-digit royalties on net product sales. $200 million is upfront payment.
Agenus will retain options to run clinical trials under the deal and to test the drug with other pipeline assets. They will co-promote AGEN1777 in the U.S. after commercialization. Agenus expects to file an Investigational New Drug (IND) application for the drug with the FDA in the second quarter of this year.
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