FDA

Durvalumab approved for limited-stage small cell lung cancer

December 9, 2024

Brand name: Imfinzi

Generic name: durvalumab

Manufacturer: AstraZeneca

Approval date: December 4, 2024

FDA approved Imfinzi (durvalumab), a programmed death-ligand 1 (PD-L1) blocking antibody, for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease hasn’t progressed following concurrent platinum-based chemotherapy and radiation therapy.

Efficacy

Efficacy was evaluated in the phase 3 ADRIATIC trial (NCT03703297) involving 730 patients with LS-SCLC whose disease hadn’t progressed following concurrent platinum-based chemotherapy and radiation therapy. Patients were randomized 1:1:1 to receive durvalumab as a single agent, durvalumab in combination with tremelimumab, or placebo.

Major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review for the comparison between durvalumab as a single agent and placebo. Durvalumab demonstrated a statistically significant OS improvement vs. placebo with a hazard ratio (HR) of 0.73 (95% CI, 0.57, 0.93; p-value, 0.0104). Median OS was 55.9 months (95% CI, 37.3, not reached) in the durvalumab arm and 33.4 months (95% CI, 25.5, 39.9) in the placebo arm. Durvalumab also demonstrated a statistically significant PFS improvement vs. placebo with HR of 0.76 (95% CI, 0.61, 0.95; p-value, 0.0161). Median PFS was 16.6 months (95% CI, 10.2, 28.2) and 9.2 months (95% CI, 7.4, 12.9) in the durvalumab and placebo arms, respectively.

Safety

The most common adverse reactions (≥20%) were pneumonitis or radiation pneumonitis and fatigue.

Recommended dose

The recommended dose of durvalumab is 1,500 mg q4wk for patients with body weight ≥30 kg and 20 mg/kg q4wks for patients with body weight <30 kg until disease progression or unacceptable toxicity or a maximum of 24 months.

Sources:

FDA. (2024, December 4). FDA approves durvalumab for limited-stage small cell lung cancer. [Press release]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer

AstraZeneca. (2024, December 5). Imfinzi approved in the US as first and only immunotherapy regimen for patients with limited-stage small cell lung cancer.[Press release]. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-approved-in-us-for-limited-stage-sclc.html

AstraZeneca: Imfinzi (durvalumab) [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s049lbl.pdf