Durvalumab is Recommended for Approval in the EU
The Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of durvalumab in the European Union (EU) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease hasn’t progressed after platinum-based chemoradiation therapy. If approved, durvalumab would become the first immunotherapy available in the EU for this patient population.
The recommendation is based on the results of the phase III ADRIATIC trial, which found that durvalumab therapy resulted in significantly longer overall survival (OS) compared with placebo, with a median OS of just under 56 months versus nearly 34 months, respectively.1 Additionally, it demonstrated significantly longer progression-free survival (PFS), with a median PFS of about 17 months versus just more than 9 months with placebo.1
The incidence of adverse events (AEs) with a maximum grade of 3 or 4 was around 24% among patients receiving durvalumab and slightly more than 24% among those receiving placebo.1 AEs that resulted in treatment discontinuation occurred in about 16% of patients in the durvalumab group and nearly 11% of patients in the placebo group.1 AEs contributed to death in almost 3% of patients receiving durvalumab and nearly 2% of patients receiving placebo.1
Canada Approves Pembrolizumab for Resectable Non-Small Cell Lung Carcinoma
Health Canada has approved pembrolizumab for patients with resectable stage II, IIIA, or IIIB non-small cell lung carcinoma. This treatment involves combining pembrolizumab with platinum-based chemotherapy as neoadjuvant therapy, which continues as monotherapy after surgery.
The decision is based on the results from the double-blind, phase III KEYNOTE-671 trial, which randomized patients 1:1 to receive neoadjuvant pembrolizumab or a placebo every 3 weeks.2 Each treatment was administered with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo once every 3 weeks for up to 13 cycles.2
Event-free survival at 24 months was almost 63% in the pembrolizumab group, compared with nearly 41% in the placebo group.2 The estimated OS at 24 months was just under 81% in the pembrolizumab group and around 78% in the placebo group, which did not meet the significance criterion.2
The US FDA Grants Priority Review to Datopotamab Deruxtecan
The US Food and Drug Administration (FDA) has accepted and granted priority review for the Biologics License Application for datopotamab deruxtecan for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. This therapy is designed for patients who have previously undergone surgery or an EGFR-directed treatment.
The FDA’s decision is supported by data from the TROPION-Lung05 trial. More than half of enrolled patients (almost 57%) had EGFR mutations, and nearly 25% had ALK rearrangements.3 The median treatment duration was just over 4 months.3 The confirmed overall response rate (ORR) was nearly 36% in patients overall; 44% in patients with EGFR mutations and just under 24% in those with ALK rearrangements.3 The median duration of response (DOR) was 7 months, and the overall disease control rate was nearly 79%.3
References:
- 1. https://www.nejm.org/doi/full/10.1056/NEJMoa2404873
- 2. https://www.nejm.org/doi/full/10.1056/NEJMoa2302983
- 3. Sands J, Ahn MJ, Lisberg A, et al. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. J Clin Oncol. Published online January 6, 2025. doi:10.1200/JCO-24-01349
