AstraZeneca's Imfinzi Fails to Meet Primary Endpoint in PACIFIC-2 Phase III Trial for NSCLC

Nov 15, 2023 13:52 CST Updated 13:52

AstraZeneca

Biopharmaceutical Manufacturer

Recently, AstraZeneca announced that its PD-L1 monoclonal antibody drug failed to meet the primary efficacy endpoint for non-small cell lung cancer in the Phase III PACIFIC-2 trial, where the drug was used in combination with chemoradiotherapy.

It was reported that although AstraZeneca did not provide specific data in the press release, the company stated that the progression-free survival (PFS) of patients treated with the Imfinzi-CRT regimen under investigation was not significantly better than that of patients receiving only chemoradiotherapy (CRT).

PACIFIC-2 Trial Finds Safety and Tolerability Profile of Imfinzi and CRT Consistent with Previously Established Data; "Increased Infection Rates" Observed in Patients Receiving Combination Therapy.

Imfinzi is a humanized monoclonal antibody. By binding to PD-L1, Imfinzi blocks the interaction between PD-L1 and PD-1 as well as CD80 proteins, thereby inhibiting the tumor's immune escape mechanism. Imfinzi has been approved in multiple countries and regions for the treatment of patients with advanced bladder cancer.

In fact, as early as February 2018, Imfinzi received FDA approval for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC). However, according to its label, Imfinzi can only be used after concurrent platinum-based chemotherapy and radiation therapy.

AstraZeneca's Executive Vice President of Oncology R&D, Susan Galbraith, said in a statement: "Our goal in the PACIFIC-2 trial is to meet the unmet needs of patients in this area by introducing immunotherapy earlier and administering Imfinzi concurrently with chemotherapy and radiotherapy."

The failure of PACIFIC-2 broke a short winning streak for Imfinzi. Last week, AstraZeneca reported that Imfinzi, when used in combination with transarterial chemoembolization and bevacizumab, demonstrated a "statistically significant and clinically meaningful" improvement in progression-free survival (PFS) for patients with hepatocellular carcinoma.

Despite the failure of PACIFIC-2, AstraZeneca stated that it will continue to advance Imfinzi into earlier stages of lung cancer treatment. The ongoing PACIFIC-4 study focuses on patients with medically inoperable or unresectable Stage I to II NSCLC, along with the PACIFIC-5, -8, and -9 trials, all of which are centered on unresectable Stage III NSCLC.

References:

1.https://www.biospace.com/article/astrazeneca-bid-to-expand-imfinzi-s-nsclc-label-hit-with-phase-iii-flop/

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