The FDA approval is supported by positive results from the Phase 3 POSEIDON study, which showed a significant survival benefit with a limited course of Imjudo added to Imfinzi and chemotherapy

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The Discovery Centre overhead view. (Credit: AstraZeneca)

AstraZeneca has obtained the US Food and Drug Administration (FDA) approval for its Imfinzi, in combination with Imjudo plus platinum-based chemotherapy to treat a type of lung cancer.

The combination is indicated for the treatment of Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins.

The anti-PD-L1 drug works by countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imjudo (tremelimumab) is an antibody therapy that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which leads to T-cell activation.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This approval underscores the importance of delivering novel treatment combinations that extend survival in metastatic non-small cell lung cancer, a complex setting where many patients still face a dismal prognosis.

“This marks the second indication for Imjudo added to Imfinzi in just a few weeks following its approval in unresectable liver cancer, reinforcing the benefits of this new medicine and our commitment to improving patient outcomes in cancer settings with continued unmet need.”

The FDA approval was supported by the results from the POSEIDON, a randomised, multi-centre, Phase 3 study of Imfinzi plus platinum-based chemotherapy, or Imfinzi plus Imjudo and chemotherapy, compared to chemotherapy alone.

The study enrolled 1,013 patients with metastatic NSCLC, including those with either non-squamous or squamous disease, and the full range of PD-L1 expression levels.

In the study, patients treated with five cycles of Imjudo plus Imfinzi, along with four cycles of platinum-based chemotherapy experienced a 23% reduction in the risk of death.

The treatment combination reduced the risk of disease progression or death by 28% compared to chemotherapy alone.

The updated results from the Phase 3 POSEIDON study, released after four years of follow-up, which showed an improved overall survival (OS) of 25% versus chemotherapy alone.

Imjudo plus Imfinzi and chemotherapy combination showed a safety profile that was consistent with the known profiles of each medicine, with no new safety signals identified.

Phase 3 POSEIDON lead investigator Melissa Johnson said: “Metastatic non-small cell lung cancer remains a significant treatment challenge because many patients’ tumours do not respond well to standard therapies, including checkpoint inhibitors.

“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.”

In a separate development, AstraZeneca has announced the roll-out of the first Alexion rare disease therapy for patients in China, expanding its global footprint in rare diseases.

Alexion, the British drugmaker’s rare diseases unit, is now offering Soliris (eculizumab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS), in China.

In addition, China’s National Medicine Products Administration of China (NMPA) has accepted its supplementary application for Soliris, said AstraZeneca.

Soliris was indicated for the treatment of adults with refractory generalised myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive.

Furthermore, AstraZeneca has also secured the NMPA nod to commence clinical trials on lupus nephritis (LN), immunoglobulin A nephropathy (IgAN) and light chain (AL) amyloidosis.

Alexion chief executive officer Marc Dunoyer said: “These milestones represent significant progress against our commitment to expand access to our rare disease medicines globally, including the introduction of innovative rare disease therapies in China.

“Expanding access to our medicines is possible because of the combined strength of Alexion’s rare disease expertise and AstraZeneca’s vast global footprint, and we look forward to continue bringing our therapies to people living with rare diseases around the world in the future.”