The Food and Drug Administration officially approved tepotinib (Tepmetko, EMD Serono, Inc.) on February 15, 2024, for adult patients with metastatic non-small cell lung cancer (NSCLC) that had mesenchymal-epithelial transition (MET) exon 14 skipping mutations.
Tepotinib received accelerated clearance for this use on February 3, 2021, after showing positive results in the VISION trial (NCT02864992), which was a multicenter, non-randomized, open-label, multicohort research. The transition to conventional approval was made after including 161 more patients and extending the follow-up period by 28 months to evaluate the duration of response.
Effectiveness was proven in 313 individuals with metastatic non-small cell lung cancer (NSCLC) carrying MET exon skipping mutations. Patients were administered a daily dose of 450 mg of tepotinib until disease progression or unacceptable toxicity occurred.
The main effectiveness criteria were Objective Response Rate (ORR) and Duration of Response (DOR), assessed by a Blinded Independent Review Committee. Out of 164 patients who had not had treatment before, the Objective Response Rate (ORR) was 57% with a 95% Confidence Interval (CI) of 49 to 65. Among the responders, 40% had a Duration of Response (DOR) of 12 months or more. Out of 149 patients who had received treatment before, the Objective Response Rate (ORR) was 45% with a 95% Confidence Interval (CI) of 37 to 53. Additionally, 36% of the responders had a Duration of Response (DOR) of 12 months or more.
The predominant adverse effects (≥20%) included edema, nausea, exhaustion, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.
The suggested dose of tepotinib is 450 mg taken orally once a day with meals.
CAR T-Cell therapy in Mumbai, India
CAR T-cell therapy, an advanced cancer treatment, is now available in Mumbai, offering hope to those suffering from some types of blood cancers. This therapy modifies a patient’s T-cells to seek out and destroy cancer cells. It is being offered by many of the leading medical centers in Mumbai, enhancing survival rates and quality of life. With advanced technology and oncologists, Mumbai is slowly becoming a hub for CAR T-cell therapy in India.