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Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.
AstraZeneca’s Imfinzi (durvalumab) and Tagrisso (osimertinib) have received positive recommendations from the National Institute for Health and Care Excellence (NICE) for the treatment of lung cancer patients in England and Wales, AstraZeneca announced in a press release on Jan. 22, 2025 (1).
Results from a Phase III trial (CASPIAN) showing that durvalumab, added to standard chemotherapy, provided a clinically significant and sustained overall survival benefit in adults with untreated extensive-stage small cell lung cancer (ES-SCLC) at three years informed NICE’s decision on Imfinzi, according to the release.
“Extensive-stage small cell lung cancer is a devastating diagnosis with a poor prognosis—with fewer than 5% of patients surviving beyond two years,” Meenali Chitnis, MD, consultant thoracic medical oncologist at Oxford University, said in the AstraZeneca press release (1). “Positive data from the CASPIAN Phase III trial marks an important breakthrough, providing clinicians with an effective treatment option of durvalumab with etoposide plus carboplatin or cisplatin.”
Osimertinib was recommended based on data from a separate Phase III trial (ADAURA) that demonstrated statistically significant and clinically meaningful improvement versus placebo. It may be offered as an adjuvant treatment option after complete tumor resection in adults with stage IB to IIIA non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (1).
AstraZeneca said in the press release that the United Kingdom has one of the worst five-year survival rates for lung cancer in Europe, with 70% of cases diagnosed at either stage III or IV, which results in “significantly” poorer outcomes (1).
“This is fantastic news for lung cancer patients,” Tom Keith-Roach, president, AstraZeneca UK, said in the release. “We are proud that these decisions by NICE mean we've had 28 positive recommendations by NICE and the SMC since 2021 across multiple cancer types and stages. This represents another step towards our bold ambition to one day eliminate cancer as a cause of death.”
To that end, Imfinzi was approved by FDA in August 2024, in combination with chemotherapy, for treating adult patients with resectable early-stage (IIA-IIB) NSCLC, just weeks after it and AstraZeneca’s Lynparza (olaparib) were approved throughout the European Union for the treatment of certain patients with primary advanced or recurrent endometrial cancer (2).
Osimertinib (under the Tagrisso brand name), meanwhile, was approved by China’s National Medical Products Administration in June 2024, in combination with pemetrexed and platinum-based chemotherapy, for first-line treatment of adult patients whose tumors have the same deletions or mutations as those mentioned above (3).
1. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.
2. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
3. AstraZeneca. Tagrisso with the Addition of Chemotherapy Approved in China as 1st-Line Treatment for Patients with EGFR-Mutated Advanced Lung Cancer. Press Release. June 26, 2024.