NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Monday issued positive opinions recommending an extended authorization for BeiGene's immunotherapy Tevimbra (tislelizumab) with chemotherapy as a first-line treatment for certain PD-L1-positive gastric, gastroesophageal junction (GEJ), and esophageal cancer patients.
In gastric and GEJ cancers, CHMP recommended approval for Tevimbra with chemo as a first-line treatment for patients with HER2-negative locally advanced unresectable or metastatic gastric and GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score greater than or equal to 5 percent. In esophageal cancer, the agency recommended Tevimbra with chemo in the first-line setting for patients with unresectable, locally advanced or metastatic esophageal cancer whose tumors express PD-L1 with a TAP score greater than or equal to 5 percent.
The TAP score, which BeiGene used in its Phase III trials of Tevimbra in these cancers, is defined as the percentage of PD-L1-positive tumor and immune cells divided by tumor area. The company used Roche's Ventana PD-L1 IHC SP263 CDx assay for PD-L1 expression analysis.
BeiGene submitted data from the Phase III RATIONALE-305 trial in gastric and GEJ cancer to support its application for approval. The results demonstrated an improvement in overall survival for patients who received Tevimbra with chemo compared to chemo alone, 15 months and 12.9 months, respectively. In the PD-L1 TAP greater than 5 percent population, the median overall survival was 16.4 months for Tevimbra plus chemo compared to 12.8 months on chemo alone.
In esophageal cancer, BeiGene submitted data from another Phase III trial, RATIONALE-306, which also demonstrated an improvement in survival across all patients. The median overall survival was 17.2 months for Tevimbra with chemo versus 10.6 months for placebo plus chemo.
In Europe, Tevimbra is also approved for the first- and second-line treatment of non-small cell lung cancer and for second-line or later treatment in an all-comer population of esophageal cancer.
BeiGene has also submitted applications seeking approval of Tevimbra in the gastric, GEJ, and esophageal cancer settings in the US. Last month, the US Food and Drug Administration's Oncologic Drugs Advisory Committee also considered data from RATIONALE-305 and RATIONALE-306 in a meeting examining the efficacy of three immunotherapies — Tevimbra, Merck's Keytruda (pembrolizumab), and Bristol Myers Squibb's Opdivo (nivolumab) — in gastric and esophageal cancer patients who are PD-L1-negative.