A flurry of significant clinical trial results were presented at the European Society for Medical Oncology (ESMO) annual meeting, impacting treatment paradigms across multiple cancer types. Key findings included AstraZeneca's success with Imfinzi in bladder cancer, Merck and Eisai's combination therapy for liver cancer, and challenges to Bristol Myers Squibb's lung cancer approach.
AstraZeneca's Imfinzi Shows Promise in Bladder Cancer
AstraZeneca's Phase 3 NIAGARA study revealed that Imfinzi, a checkpoint inhibitor, significantly improved survival rates in bladder cancer patients. The study demonstrated a 25% reduction in the risk of death when Imfinzi was administered both before and after surgery. "I think they liked that one," commented Rebecca Dent, an oncologist at the National Cancer Centre Singapore, highlighting the positive reception of the data. AstraZeneca plans to submit these data to regulatory authorities. However, the trial design, which combines pre- and post-operative treatment without isolating the effects of each phase, may face regulatory scrutiny from the FDA.
Merck and Eisai's Keytruda/Lenvima Combination Excels in Liver Cancer
Merck and Eisai's collaboration yielded positive results in liver cancer, where the combination of Keytruda and Lenvima, when added to transarterial chemoembolization (TACE), improved outcomes in hepatocellular carcinoma (HCC). The LEAP-012 study showed that patients receiving the combination therapy had a median progression-free survival of 14.6 months, compared to 10 months for those receiving TACE plus placebo. Josep Llovet of the University of Barcelona described this difference as "profound." While overall survival data are still pending, the companies are likely to await these results before engaging with regulators. Eliav Barr, Merck’s chief medical officer, noted that the increased side effects observed in the treatment arm were consistent with the known profiles of Keytruda and Lenvima. Angela Lamarca from Fundacion Jimenez Diaz University Hospital in Madrid suggested that the addition of these drugs to TACE could become the new standard of care, even before overall survival benefits are fully demonstrated.
Bristol Myers Squibb's Lung Cancer Strategy Faces Criticism
Bristol Myers Squibb's approach of combining Opdivo (a PD-1 inhibitor) and relatlimab (a LAG-3 targeting antibody) in non-small cell lung cancer (NSCLC) is under scrutiny. Data from the Phase 2 RELATIVITY-104 study, which led to a Phase 3 trial (RELATIVITY-1093) focusing on patients with non-squamous NSCLC and intermediate PD-L1 expression (1% to 49%), have been met with skepticism. Marina Chiara Garassino of the University of Chicago criticized the subgroup analysis as "cherry-picking." She also pointed out that historical data with PD-1 inhibitors alone have shown similar progression-free survival rates in patients with intermediate PD-L1 expression, questioning the added benefit of relatlimab. Jacob Plieth, writing in ApexOnco, suggested that the delayed release of the Phase 2 results and the late initiation of the Phase 3 trial indicate underlying concerns about the data.
