FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

Regulatory approval: On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra; Amgen) for extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Approval was based on ORR and DOR from the open-label DeLLphi-301 study (n=99). ORR was 40% (95% CI 31–51) with a median DOR of 9.7 months (range 2.7–20.7+). Continued approval may be contingent on confirmatory evidence of clinical benefit.

FDA accelerated approval: tarlatamab-dlle in ES-SCLC (May 16, 2024)

Type: Regulatory approval (accelerated approval)
Agency/date: FDA, 2024-05-16
Product: tarlatamab-dlle (Imdelltra; Amgen, Inc.)
Indication: Extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Supporting evidence

Efficacy and safety were evaluated in DeLLphi-301 (NCT05060016), an open-label, multicenter, multi-cohort study enrolling 99 patients with relapsed/refractory ES-SCLC with progression following platinum-based chemotherapy. Patients with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. Treatment continued until disease progression or unacceptable toxicity.

Primary efficacy outcomes (blinded independent central review; RECIST 1.1):

  • ORR: 40% (95% CI, 31–51)
  • Median DOR: 9.7 months (range, 2.7–20.7+)

Among 69 patients with available platinum sensitivity data:

  • Platinum-resistant (<90 days): ORR 52% (95% CI, 32–71) (n=27)
  • Platinum-sensitive (≥90 days): ORR 31% (95% CI, 18–47) (n=42)

Safety and dosing highlights from prescribing information

Includes a Boxed Warning for serious/life-threatening CRS and neurologic toxicity, including ICANS.

Recommended dosing: 1 mg IV (Cycle 1 Day 1), then 10 mg (Cycle 1 Day 8 and Day 15), then every 2 weeks thereafter.

Regulatory context

The FDA noted accelerated approval was granted based on ORR and DOR; continued approval may be contingent upon verification of clinical benefit. Review used Project Orbis and RTOR; partner-agency reviews are ongoing.

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