Oncology
November 29, 2024
The European Commission has approved tislelizumab in combination with chemotherapy for the first-line treatment of squamous cell carcinoma of the esophagus and gastric or gastroesophageal junction adenocarcinoma
The European Commission has approved tislelizumab in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (Escc) and gastric or gastroesophageal junction adenocarcinoma (G/Gej). This was announced in a note by BeiGene, a global oncology company that intends to change its name to BeOne Medicines.
In Escc, the extended indication is for tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic PD-L1-expressing cancer with a positive score of tumor area (Tap) ≥ 5%. In G/Gej adenocarcinoma, the extended indication is in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic Her2-negative locally advanced tumor with PD-L1 expression with a TAP score ≥ 5%.
“As a cornerstone of our solid tumor portfolio, tislelizumab is central to BeiGene’s commitment to providing innovative treatments to as many cancer patients as possible, with more than 1.3 million patients already treated with the drug globally – says Mark Lanasa, Chief Medical Officer, Solid Tumors, BeiGene – In just over a year, we have obtained approval for 6 indications in the European Union and we look forward to being able to guarantee European patients a broad and rapid access to tislelizumab”.
In the frontline of ESCC, the indication extension is based on the results of BeiGene’s Rationale-306 study (NCT03783442), a global phase 3 randomized, controlled, double-blind study evaluating efficacy and safety of tislelizumab in combination with chemotherapy as first-line treatment of patients with unresectable, relapsed or metastatic locally advanced disease. The study, which enrolled 649 patients across centers in Europe, North America and Asia-Pacific, met its primary endpoint, achieving a statistically significant and clinically relevant overall survival (OS) benefit of tislelizumab in combination with chemotherapy, compared to placebo plus chemotherapy in the intent-to-treat population. The median overall survival was 17.2 months in the group treated with tislelizumab compared to 10.6 months with placebo with a reduction in the risk of death of 34%. The 3-year survival in the population with PD-L1 expression ≥ 5% is better in favor of the tislelizumab arm (median 19.1 versus 10.0 months), demonstrating a 38% reduction in the risk of death.
The request to extend the indication to the frontline of G/Gej cancer is based on the results of BeiGene’s Rationale-305 study (NCT03777657), a global phase 3 randomized, double-blind, controlled study evaluating the efficacy and of the safety of tislelizumab in combination with chemotherapy as first-line treatment of patients with advanced or metastatic unresectable G/Gej cancer. The study, which enrolled 997 patients at centers in Europe, North America and Asia-Pacific, met its primary endpoint and demonstrated a statistically significant and clinically relevant overall survival (OS) benefit with a median survival of 15.0 months in patients treated with tislelizumab in combination with investigator’s choice chemotherapy, compared to 12.9 months in patients treated with placebo plus chemotherapy, reporting a 20% reduction in the risk of death. In the population with PD-L1 ≥ 5%, median survival was 16.4 months with tislelizumab plus chemotherapy compared to 12.8 months for the placebo arm, representing a 29% reduction in the risk of death.
The reported safety data include more than 2,800 patients treated with tislelizumab either as monotherapy (1,534) or in combination with chemotherapy (1,319) at the approved dosage. The most common grade 3 or 4 adverse reactions (≥ 2%) were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, lymphopenia, increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea and hepatitis. Tislelizumab is also approved in the EU for patients with unresectable locally advanced or metastatic ESCC, after prior platinum-based chemotherapy, and for three indications in NSCLC in first- and second-line settings. The company recently announced plans to change its name to BeOne Medicines Ltd, reaffirming its commitment to developing innovative medicines to eliminate cancer by working with the international community to reach as many patients as possible.
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## Tislelizumab Show promise for Esophageal and Gastric Cancers
**World-Today-News Expert Interview**
**Dr. [Expert Name]**,
**senior Oncologist at [Hospital/Institution]**
**World-today-News:** Dr.[Expert Name], the European Commission recently approved tislelizumab in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (escc) and gastric or gastroesophageal junction adenocarcinoma (G/Gej). Could you explain the significance of this approval?
**Dr. [Expert Name]:** Absolutely. This is exciting news for patients with these highly challenging cancers.tislelizumab is a programmed cell death protein 1 (PD-1) inhibitor, a type of immunotherapy that helps the body’s own immune system fight cancer cells. The approval in these first-line settings, meaning as an initial treatment, offers a new treatment option with the potential to improve survival outcomes.
**World-Today-News:** The approval is based on the results of two Phase 3 clinical trials: Rationale-306 for ESCC and Rationale-305 for G/Gej. Can you discuss the key findings of these studies?
**Dr. [Expert Name]:** Both trials demonstrated a statistically meaningful benefit in overall survival for patients receiving tislelizumab in combination with chemotherapy compared to chemotherapy alone. In the Rationale-306 study for ESCC, the median overall survival was 17.2 months for the tislelizumab group compared to 10.6 months for the chemotherapy-alone group. Similarly, the Rationale-305 study for G/Gej showed a median overall survival of 15.0 months for the tislelizumab group compared to 12.9 months for the chemotherapy-alone group. These findings are crucial as they indicate a potential for tislelizumab to extend the lives of patients with these aggressive cancers.
**World-Today-News:** Are there specific subgroups of patients who are most likely to benefit from tislelizumab treatment?
**Dr. [expert Name]: ** Yes, both trials focused on patients whose tumors expressed PD-L1, a protein that can help cancer cells evade the immune system.The benefits were particularly pronounced in patients with higher PD-L1 expression levels.
**World-Today-news:** What are the potential side effects associated with tislelizumab?
**Dr. [Expert Name]:** Like all cancer therapies, tislelizumab can have side effects. The most common side effects reported in the trials were gastrointestinal issues, fatigue, and blood count abnormalities. Though, these were generally manageable. It’s important to emphasize that each patient’s experience may vary, and doctors carefully monitor patients for potential side effects.
**World-Today-News:** What are your hopes for the future of tislelizumab in the treatment of these cancers?
**Dr. [Expert Name]:** This approval is a significant step forward. I anticipate that further research will continue to explore the potential of tislelizumab, perhaps in combination with other therapies, to further improve outcomes for patients with ESCC and G/Gej.
**World-Today-News:** Thank you for sharing your insights, Dr.[Expert Name].
