Bristol-Myers Squibb (BMS) has announced a strategic collaboration with French biotech Transgene to evaluate a novel combination therapy approach for non-small cell lung cancer (NSCLC) patients with low or undetectable PD-L1 levels, addressing a significant unmet need in lung cancer treatment.
The partnership will investigate the combination of BMS's checkpoint inhibitor Opdivo (nivolumab) with Transgene's investigational therapeutic vaccine TG4010, alongside standard chemotherapy in first-line NSCLC patients. This approach represents a new strategy in BMS's efforts to expand treatment options beyond current PD-1/PD-L1 monotherapy limitations.
Mechanism of Action and Scientific Rationale
TG4010 is engineered to generate immune responses against MUC1-expressing tumors, effectively serving as an immune system accelerator. When combined with Opdivo, which removes immune system inhibition, the dual approach could potentially enhance anti-tumor responses. The addition of standard chemotherapy creates a three-pronged treatment strategy targeting these difficult-to-treat cancers.
Trial Design and Objectives
The Phase 2 trial will focus on evaluating:
- Objective tumor responses in patients with low/undetectable PD-L1 expression
- Disease control rates
- Safety and tolerability of the combination regimen
- Additional efficacy metrics
The multi-center, single-arm study is expected to deliver initial results in 2018, with Transgene serving as the trial sponsor and BMS providing Opdivo for the investigation.
Strategic Context and Market Implications
This collaboration comes at a crucial time for BMS, following Opdivo's unexpected failure in first-line NSCLC monotherapy trials in 2016. While Opdivo maintains its position as a market leader in PD-1/PD-L1 immunotherapies, Merck's Keytruda has gained significant ground, particularly in first-line NSCLC treatment.
"We are excited to explore the potential benefits of combining Opdivo with an investigational therapeutic vaccine, TG4010, in NSCLC where the need for new therapies is particularly acute," said Fouad Namouni, M.D., Head of Oncology Development at BMS. "As the science around cancer research continues to rapidly evolve, we are building on our leadership in Immuno-Oncology with potential combinations of therapies that may help advance new therapeutic approaches for patients in need of better options."
Emerging Therapeutic Landscape
The collaboration reflects a broader industry trend toward therapeutic vaccine combinations with checkpoint inhibitors. BMS has already established a similar partnership with Bavarian Nordic, demonstrating their commitment to exploring multiple approaches in this space.
Recent data from Opdivo-Yervoy combination studies have shown promising results in first-line advanced NSCLC, with doubled median progression-free survival compared to Opdivo monotherapy across all patients, and tripled PFS in PD-L1-expressing patients. These results suggest the potential value of combination approaches in expanding treatment options for NSCLC patients.
