FDA Approves Tarlatamab After Progression on Chemotherapy in ES-SCLC
The phase 2 DELLphi-301 trial showed durable response rates when tarlatamab was used to treat extensive-stage small cell lung cancer.
The FDA gave tarlatamab priority review in this indication in December 2023.
Tarlatamab-dlle (Imdelltra) has been granted accelerated approval by the FDA for patients with extensive-stage small cell lung cancer who have progressed on platinum-based chemotherapy, according to a press release from the agency.1
Results from the phase 2 DELLphi-301 trial (NCT05060016) helped lead to the approval.2 Results published in 2023 showed an objective response rate (ORR) of 40.0% (97.5% CI, 29.1%-51.7%) for those given tarlatamab at 10 mg and 31.8% (97.5% CI, 21.1%-44.1%) in those given 100 mg. The median overall survival (OS) was 14.3 months (95% CI, 10.8-not evaluable [NE]) and NE (95% CI, 12.4-NE), and the median progression-free survival (PFS) was 4.9 months (95% CI, 2.9-6.7) and 3.9 months (95% CI, 2.6-4.4) between both doses. Between both cohorts, the median duration of response (DOR) was NE.
The most common treatment-emergent adverse effects (TRAEs) included cytokine release syndrome in 51.1% of the 10 mg group and 60.9% in the 100 mg group. In each respective arm, 3.0% and 3.4% of patients discontinued treatment due to TRAEs.
Patients were given treatment with tarlatamab intravenously every 2 weeks at either 10 mg or 100 mg. The primary end point was ORR assessed by a blinded independent central review committee. Secondary end points included DOR, PFS, OS, and TRAEs.
The FDA gave tarlatamab priority review in this indication in December 2023.3
“The FDA's priority review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy… For patients who relapse, there are limited treatment options, emphasizing the importance of bringing new therapies to this patient population with advanced disease,” David M. Reese, MD, executive vice president of Research and Development at Amgen, said in a press release at the time of the priority review.3
References
- FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer. News release. FDA. May 16, 2024. Accessed May 16, 2024. https://tinyurl.com/48k34rw5
- Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med. 2023;389:2063-2075. doi:10.1056/NEJMoa2307980
- FDA grants priority review to Amgen's tarlatamab application for advanced small cell lung cancer. News release. Amgen. December 13, 2023. Accessed December 14, 2023. https://prn.to/47X7yu7
