Home Medizin FDA genehmigt neues Medikament gegen Speiseröhrenkrebs

FDA genehmigt neues Medikament gegen Speiseröhrenkrebs

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved Tislelizumab-jsgr (Tevimbra, BeiGene, Ltd.) as a second-line monotherapy for certain adult patients with inoperable or metastatic esophageal squamous cell carcinoma (ESCC).

Specifically, the novel checkpoint inhibitor is approved for patients with ESCC who have received prior systemic chemotherapy that did not include a PD-L1 inhibitor (Programmed Death Ligand 1).

The approval was based on results from the open-label Phase 3 study RATIONALE 302, which demonstrated a statistically significant and clinically meaningful overall survival benefit with Tislelizumab compared to investigator’s choice chemotherapy.

The study included 512 adults enrolled at 123 research sites in 11 countries across Europe, Asia, and North America. Patients were randomly assigned to receive intravenous Tislelizumab, a humanized monoclonal antibody targeting programmed cell death protein 1 of immunoglobulin G4, at a dose of 200 mg every 3 weeks, or investigator’s choice of standard chemotherapy with Paclitaxel, Docetaxel, or Irinotecan until disease progression, unacceptable toxicity, or study discontinuation.

In the intention-to-treat population, the median overall survival was 8.6 months with Tislelizumab compared to 6.3 months in the chemotherapy arms (hazard ratio [HR], 0.70). The survival benefit was observed in predefined subgroups, including PD-L1 status and region. The new agent was also associated with an improved overall response rate (20.4% vs. 9.8%) and longer duration of response (mean duration of response 7.1 vs. 4.0 months; HR 0.42) compared to chemotherapy.

The most common adverse events with Tislelizumab, occurring in at least 20% of treated patients, included increased glucose, decreased hemoglobin, lymphocytes, sodium, and albumin levels, as well as increased alkaline phosphatase, anemia, fatigue, increased aspartate aminotransferase, musculoskeletal pain, weight loss, increased alanine aminotransferase, and cough.

Fewer Tislelizumab-treated patients experienced treatment-related grade 3 or higher adverse events compared to the chemotherapy arm (46% vs. 68%), and fewer patients discontinued Tislelizumab due to such events compared to chemotherapy (7% vs. 14%).

„For patients diagnosed with advanced or metastatic ESCC, which is the most common histological subtype of esophageal cancer, progression often occurs after initial therapy, necessitating new options,“ said Dr. Syma Iqbal from the Norris Comprehensive Cancer Center at the Keck School of Medicine, University of Southern California, in the BeiGene press release. „The RATIONALE 302 study showed that patients with previously treated ESCC who received Tevimbra saw a clinically meaningful survival benefit, underscoring the potential of Tevimbra as a key treatment option for these patients.“

The approval, which was delayed to 2022 due to COVID-19-related restrictions, marks the first approval for the agent in the United States. BeiGene plans to make Tislelizumab available in the US in the second half of 2024.

The FDA is also reviewing a Biologics License Application for the agent as a first-line treatment for patients with inoperable, locally advanced, or metastatic ESCC and for patients with locally advanced inoperable or metastatic adenocarcinoma of the stomach or gastroesophageal junction, BeiGene announced in a press release.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, who writes for Medscape, MDedge, and other partner sites. She currently focuses on oncology but has also written about a variety of other medical specialties and health topics. She can be reached at sworcester@mdedge.com or on Twitter: @SW_MedReporter.

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