New Hope for Advanced Lung Cancer Patients: FDA Approves Tarlatamab
Key Takeaways
- FDA approves tarlatamab for advanced small cell lung cancer post-chemotherapy failure
- Phase 2 trial shows promising objective response and survival rates
- Cytokine release syndrome identified as a common side effect
Did You Know?
FDA Approves Tarlatamab for Advanced Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has recently given accelerated approval for tarlatamab, a promising new treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) who have seen their disease progress after platinum-based chemotherapy.
What is Tarlatamab?
Tarlatamab, also known as Imdelltra, is an innovative medication that targets cancer cells in patients with ES-SCLC. This new drug has shown significant promise in clinical trials, offering new hope for patients who have limited treatment options after their initial chemotherapy fails.
Critical Trial Results
The approval of tarlatamab is largely based on the results from the phase 2 DELLphi-301 trial (NCT05060016). This trial has shown durable response rates, which indicates that the treatment is effectively controlling the cancer for an extended period.
Objective Response Rate (ORR)
The results published in 2023 demonstrated an impressive objective response rate (ORR). Patients treated with tarlatamab at doses of 10 mg had an ORR of 40% while those given 100 mg had an ORR of 31.8%. These figures highlight the drug's effectiveness in shrinking tumors and controlling the disease.
Survival Rates
The trial also showed encouraging median overall survival (OS) times of 14.3 months for the 10 mg dose group and a yet-to-be-evaluated time for the 100 mg group. The progression-free survival (PFS) was 4.9 months for the 10 mg group and 3.9 months for the 100 mg group. These results suggest tarlatamab can provide patients with more time before their disease worsens.
Safety and Side Effects
Like all medications, tarlatamab comes with potential side effects. The most common treatment-emergent adverse effects (TRAEs) observed were cytokine release syndrome, affecting 51.1% of the 10 mg group and 60.9% of the 100 mg group. A small percentage of patients in each group discontinued treatment due to these adverse effects.
Administration and Dosing
Patients involved in the DELLphi-301 trial received tarlatamab intravenously every two weeks at either 10 mg or 100 mg doses. This regular administration ensures that the drug maintains its therapeutic levels in the patient's body to effectively combat cancer cells.
FDA's Priority Review
The FDA granted priority review for tarlatamab in December 2023, underscoring the urgent need for new treatment options for patients with advanced SCLC. This designation is given to drugs that offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
Expert Opinions
Dr. David M. Reese, MD, executive vice president of Research and Development at Amgen, stated, “The FDA's priority review designation emphasizes the pressing need to provide new treatment options for patients with advanced SCLC who have progressed after chemotherapy. Bringing new therapies to this patient population with advanced disease is crucial.”
The Future of Tarlatamab
With its recent FDA approval, tarlatamab is poised to become a crucial option for patients battling extensive-stage small cell lung cancer. Ongoing research and upcoming trials will continue to shed light on its long-term efficacy and safety, giving hope to patients and healthcare providers alike.
