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Tislelizumab is approved in combination with platinum and fluoropyrimidine-based chemotherapy as first-line treatment of unresectable or metastatic HER2-negative tumors.
The FDA approved tislelizumab-jsgr (Tevimbra; BeiGene Ltd) in combination with platinum and fluoropyrimidine-based chemotherapy as first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) for tumors that express programmed cell death ligand 1 (PD-L1).1
FDA Approval, Oncology, Gastric Cancer | Image Credit: © wladimir1804 | stock.adobe.com
“[The] FDA approval of Tevimbra for the treatment of gastric or gastroesophageal junction cancers in PD-L1–positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer,” Mark Lanasa, MD, PhD, chief medical officer of solid tumors at BeiGene, said in a news release. “This is the second US approval for Tevimbra [in 2024], underscoring its potential to address critical needs in oncology.”1
The new approval is based on data from a randomized, double-blind, placebo-controlled phase 3 study (NCT03777657). The study compared the efficacy and safety of tislelizumab plus chemotherapy compared with the placebo plus chemotherapy as first line treatment for locally advanced unresectable or metastatic G/GEJ. Patients included those with locally advanced unresectable or metastatic G/GEJ with histologically confirmed adenocarcinoma, no previous systemic therapy for the target cancer, and adequate organ function. Further, patients were excluded if they had squamous cell, undifferentiated, or other histological type G, active leptomeningeal disease or uncontrolled brain metastasis; a diagnosis of gastric or GEJ with positive HER2; or prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug targeting T-cell stimulation or checkpoints.2
Trial Name: Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
ClinicalTrials.gov ID: NCT03777657
Sponsor: BeiGene
Completion Date: August 2024
In the study, investigators randomized treatment for patients of either tislelizumab (200 mg intravenously on day 1 during each 21-day cycle) in combination with chemotherapy (oxaliplatin [30 mg/m² IV on day 1 during each 21-day cycle], capecitabine [1000 mg/m² orally twice daily on days 1 through 14 during each 21-day cycle] or cisplatin [80 mg/m² day 1 during each 21-day cycle], and 5-flurouracil [800 mg/m²/day using a continuous pumping system on days 1 through 5 during each 21-day cycle]) or the placebo in place of tislelizumab with chemotherapy.2
The primary end point was overall survival up to 48 months, and secondary outcomes included progression free survival up to 30 months; overall response rate up to 48 months; duration of response from baseline at every cycle through cycle 6, then every other cycle for up to 48 months; number of individuals with adverse events; number of individuals with serious adverse events (both through 48 months); disease control rate; clinical benefit rate; and time to response up to 48 months.2
Investigators reported that the study met the primary end point with a median OS of 15 months for the study drug compared with the placebo at 12.9 months indicating a 20% reduction in the risk of death, according to the news release. For safety, a pooled 1972 individuals were included across 2 randomized studies and 5 open-label studies. The most common grade 3 or 4 AEs included neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea, pneumonitis, and hepatitis.1
According to the news release, tislelizumab is also approved as a monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)q inhibitor.1
