One hit, one miss for AstraZeneca’s Imfinzi in bladder, lung cancer studies
25 Jun 2024
Clinical ResultPhase 3Drug ApprovalImmunotherapyAccelerated Approval
AstraZeneca announced Tuesday positive top-line results from a Phase III study of Imfinzi (durvalumab) plus chemotherapy, demonstrating survival gains over neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC). However, the PD-L1 inhibitor’s success was dampened by findings from another late-stage trial in early-stage non-small-cell lung cancer (NSCLC), where it failed to meet the key survival endpoint against placebo.
Survival advantage in MIBC
In the Phase III NIAGARA study, 1063 patients with MIBC were randomly assigned to either Imfinzi plus chemotherapy or chemotherapy alone before undergoing cystectomy, followed by Imfinzi or no further treatment after surgery. Data showed that patients treated with Imfinzi plus chemotherapy had a significant and clinically meaningful improvement on the main goal of event-free survival (EFS) and also on the key secondary endpoint of overall survival (OS) compared with those receiving only neoadjuvant chemotherapy.
According to AstraZeneca, the addition of Imfinzi did not increase the discontinuation rate due to adverse events and did not compromise patients' ability to complete surgery compared to neoadjuvant chemotherapy alone.
“The NIAGARA results support our strategy to move immunotherapy to the early stages of cancer treatment,” said Susan Galbraith, EVP of oncology R&D at AstraZeneca, adding that Imfinzi has the “potential to transform the standard of care” for MIBC. The company indicated that the results will be presented at an upcoming medical meeting and submitted to regulatory authorities.
Imfinzi received accelerated FDA clearance in 2017 for treating advanced bladder cancer, but this indication was voluntarily withdrawn in 2021 after a confirmatory trial failed. The drugmaker noted that Imfinzi is currently being investigated in early- and late-stage bladder cancer across multiple settings in various treatment combinations.
Endpoint missed in NSCLC
Meanwhile, the Phase III ADJUVANT BR.31 study enrolled 1415 patients with Stage IB, II or IIIA NSCLC having 25% or more expression of PD-L1 on tumour cells. Participants were randomised to receive either Imfinzi or placebo following resection every four weeks for up to 48 weeks. Results showed that Imfinzi did not meet the primary endpoint of disease-free survival versus placebo.
Despite the unfavourable results of the study, “Imfinzi has helped change the treatment landscape and achieved multiple positive Phase III trials for patients with earlier stages of lung cancer,” Galbraith remarked.
The PD-L1 inhibitor is currently approved for patients with unresectable Stage III NSCLC not having experienced disease progression following chemoradiation in the curative-intent setting, as well as for treating metastatic NSCLC in combination with AstraZeneca’s anti-CTLA-4 antibody Imjudo (tremelimumab) and chemotherapy. Imfinzi generated sales of $4.2 billion last year.
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