In November 2022, 2 weeks after the initial approval of Imjudo (tremelimumab; from AstraZeneca), a CTLA-4 inhibitor, the FDA approved this new immunotherapy, again in combination with another immunotherapy, Imfinzi (durvalumab; from AstraZeneca), a PD-L1 inhibitor, plus platinum-based chemotherapy for the treatment of adults with metastatic (spreading) non–small-cell lung cancer (or NSCLC) that does not have EGFR or ALK genomic aberrations.
“The approval of this dual immunotherapy regimen with chemotherapy introduces a new, generally well-tolerated treatment option for patients with this devastating disease and gives them the chance to benefit from the long-term survival advantage seen with CTLA-4 inhibition,” said Melissa Johnson, MD, Director of Lung Cancer Research, Sarah Cannon Research Institute, Tennessee Oncology, Nashville.
The FDA approval was based on the results of the phase 3 clinical trial in 675 patients with metastatic NSCLC who received either the immunotherapy combination plus chemotherapy or chemotherapy alone.
The overall survival was significantly longer with the 2 immunotherapies plus chemotherapy compared with chemotherapy alone. The average survival was 14 months with the dual immunotherapy plus chemotherapy versus 11.7 months with chemotherapy alone.
The average time without disease progression was 6.2 months with the combination versus 4.8 months with chemotherapy alone. Overall, 39% of patients responded to treatment with the 2 immunotherapies plus chemotherapy versus 4% of patients who responded to chemotherapy alone. The average duration of response was 9.5 months with the combination versus 5.1 months with chemotherapy alone.
The most common side effects were nausea, fatigue, decreased appetite, musculoskeletal pain, rash, and diarrhea. Serious laboratory abnormalities were neutropenia, anemia, leukopenia, lymphocytopenia, increased lipase, hyponatremia, and thrombocytopenia.
