FDA approves therapies for lung, pancreatic cancers
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The FDA approved two oncology therapies for treatment of certain patients with lung cancer or pancreatic cancer.
The agency approved durvalumab (Imfinzi, AstraZeneca) for use by adults with limited-stage small cell lung cancer whose disease had not progressed after concurrent platinum-based chemotherapy and radiation therapy.
The agency based approval on results of the randomized phase 3 ADRIATIC trial, which included 730 patients.
Researchers randomly assigned trial participants 1:1:1 to single-agent durvalumab, durvalumab in combination with tremelimumab (Imjudo, AstraZeneca), or placebo.
OS and PFS per blinded independent central review between single-agent durvalumab and placebo served as the major efficacy outcome measures.
Results showed statistically significant improvements in OS (median, 55.9 months vs. 33.4 months; HR = 0.73; 95% CI, 0.57-0.93) and PFS (median, 16.6 months vs. 9.2 months; HR = 0.76; 95% CI, 0.61-0.95) in the durvalumab group.
The most common adverse events included pneumonitis/radiation pneumonitis and fatigue.
The FDA also granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for two indications.
One applies to use of the agent by adults with advanced, unresectable or metastatic non-small cell lung cancer who harbor a neuregulin 1 (NRG1) gene fusion who experienced disease progression on or after prior systemic therapy.
The other is for patients with advanced, unresectable or metastatic pancreatic adenocarcinoma who harbor NRG1 gene fusion1 whose disease progressed on or after prior systemic therapy.
The agency based approval on results of the multicenter, open-label eNRGy study, which included 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma who experienced disease progression after standard treatment.
Confirmed overall response rate and duration of response per blinded independent central review served as the major efficacy outcome measures.
In the NSCLC group, results showed an ORR of 33% (95% CI; 22-46) and a median response duration of 7.4 months (95% CI; 4-16.6).
In the pancreatic adenocarcinoma group, results showed an ORR of 40% (95% CI; 23-59), with a response duration range of 3.7 months to 16.6 months.
A pooled safety analysis showed the most common adverse events included diarrhea, musculoskeletal pain, nausea, fatigue, infusion-related reactions, rash, dyspnea, constipation, vomiting, abdominal pain and edema.
The most common grade 3 or grade 4 laboratory abnormalities included increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium and decreased platelets.
The label for zenocutuzumab-zbco includes a boxed warning for embryo-fetal toxicity.
References:
- FDA approves durvalumab for limited-stage small cell lung cancer (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery. Published Dec. 4, 2024. Accessed Dec. 5, 2024.
- FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic. Published Dec. 4, 2024. Accessed Dec. 5, 2024.
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