You win some, you lose some: AstraZeneca’s blockbuster cancer medicine Imfinzi has succeeded in a late-stage bladder cancer trial, but disappointed in a separate Phase 3 lung cancer study.
The anti-PD-L1 drug plus chemotherapy saw a “statistically significant and clinically meaningful improvement” in the primary endpoint of event-free survival and secondary endpoint of overall survival in muscle-invasive bladder cancer (MIBC), according to a company release Tuesday.
The Phase 3 NIAGARA trial studied the treatment regimen versus chemotherapy in 1,063 MIBC patients prior to bladder removal, followed by Imfinzi versus no treatment after the procedure.
But in another Phase 3 study, sponsored by the Canadian Cancer Trials Group, Imfinzi did not reach statistical significance versus placebo in the disease-free survival primary endpoint in non-small cell lung cancer patients, according to a separate Tuesday release.
The ADJUVANT BR.31 trial studied the drug in 1,415 people with stage IB, II or IIIA NSCLC who had complete tumor resection and whose tumors expressed PD-L1 on at least a quarter of diseased cells.
In the first three months of the year, the blockbuster drug’s sales grew 33% compared to the same period in 2023, to $1.11 billion. The drug is approved for certain forms of bladder cancer, pancreatic cancer, biliary tract cancer, hepatocellular carcinoma and lung cancer.
Earlier this month, Imfinzi won an FDA label expansion for mismatch repair-deficient primary advanced or recurrent endometrial cancer. In April, AstraZeneca unveiled positive data from a Phase 3 trial of the drug in limited-stage small cell lung cancer patients who had not progressed after concurrent chemoradiotherapy, justifying a potential shift to earlier stages of the disease.
Cristian MassacesiAt that time, CMO Cristian Massacesi told Endpoints News that immunotherapy drugs like Imfinzi not only help shrink a tumor, but also maintain patient responses. “This is a new approach. This is why chemotherapy did not make any progress in space,” he said. “We needed a different mechanism of action — immunotherapeutics.”
But Imfinzi has also faced late-stage setbacks before. In November, the anti-PD-L1 combined with chemoradiotherapy missed the primary endpoint of progression-free survival in patients with unresectable stage III NSCLC. In December 2022, the drug failed as a single agent to boost survival in stage IV metastatic NSCLC patients with tumor cells that expressed 25% or more PD-L1.
In NIAGARA, adding Imfinzi to chemotherapy did not increase the discontinuation rate due to adverse events or affect bladder cancer patients’ ability to complete surgery, according to AstraZeneca. The company plans to present NIAGARA data at an upcoming medical meeting and share them with regulatory agencies.