EMA’s CHMP Gives Positive Opinion for Durvalumab/Tremelimumab Combo in Liver and Lung Cancer

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Durvalumab plus tremelimumab has been recommended for approval in the European Union for treatment of advanced liver and lung cancers.

The European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion on the use of durvalumab (Imfinzi) combined with tremelimumab (Imjudo) to treat advanced lung and liver cancers, according to a press release from AstraZeneca.1

The combination’s liver cancer indication was supported by findings from the phase 3 HIMALAYA trial (NCT03298451), which highlighted an overall survival rate of 16.43 months with single tremelimumab, regular interval durvalumab, 16.56 months with durvalumab alone, and 13.77 months with sorafenib.2

“The combination of [tremelimumab] and [durvalumab] demonstrated a meaningful improvement in overall survival with no increase in severe liver toxicity or bleeding risk, which are important considerations for these patients who often have advanced disease,” lead investigator Bruno Sangro, MD, PhD, director of the Liver Unit at Clínica Universidad de Navarra and Professor of Internal Medicine at the University of Navarra School of Medicine, said in the press release.

Additionally, data from the phase 3 POSEIDON study (NCT03164616) supported the use of durvalumab plus tremelimumab and chemotherapy, with investigators reporting a median progression-free survival of 5.5 months vs 4.8 months with the triplet regimen and chemotherapy, respectively.3

“Metastatic non-small cell lung cancer remains a complex and devastating diagnosis and there is still an urgent need for new life-extending treatment options,” principal investigator Solange Peters, MD, PhD, president of the European Society for Medical Oncology and head of the medical oncology service and chair of thoracic oncology at Hospitalier Universitaire Vaudois, Lausanne, Switzerland, said in the press release. “The latest data from the POSEIDON trial demonstrate the long-term survival benefit of [tremelimumab] added to [durvalumab] and chemotherapy and support the important role this novel combination could have for patients with metastatic non-small cell lung cancer in Europe.”

The FDA approved durvalumab and tremelimumab to treat unresectable hepatocellular carcinoma—a type of liver cancer—in October 2022 and tremelimumab, durvalumab, and platinum-based chemotherapy was approved in November 2022 for advanced non–small cell lung cancer.4,5

References

  1. Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers. News release. AstraZeneca. December 19, 2022. Accessed December 19, 2022. https://bit.ly/3v2TLR2
  2. Abou-Alfa G, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. N Engl J Med Evid. 2022:1(8). doi:10.1056/EVIDoa2100070
  3. Johnson M, Cho BC, Luft A, et al. Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non–small-cell lung cancer: the phase III POSEIDON study. J Clin Oncol. Published online November 3, 2022. doi:10.1200/JCO.22.00975
  4. Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer. News Release. AstraZeneca. October 24, 2022. Accessed December 19, 2022. https://bit.ly/3Fbwx1w
  5. FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer. News release. FDA. November 10, 2022. Accessed December 19, 2022. https://bit.ly/3Us5sf8
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