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Phase 2 DeLLphi-301 primary analysis of Tarlatamab in previously treated small cell lung cancer (SCLC).

Tarlatamab 10 mg: Paving the Way with Durable Anticancer Impact and Manageable Safety - Empowering Previously-Treated SCLC Patients

Small-cell lung cancer (SCLC) accounts for ~15% of all lung cancer cases and is known for its high fatality rate. About two-thirds of SCLC patients are diagnosed with cancer that has already spread beyond the lungs, and the average survival time for those with advanced-stage disease is just a little over one year. While the introduction of PD-L1 inhibitors as a part of the initial treatment for SCLC patients marked significant progress, the limited improvement in survival underscores the pressing requirement for new approaches to enhance the treatment of this condition. With very limited treatment options available for patients suffering from SCLC, bispecific T-cell engager (BiTE) seems to be a potential target for treatment development. With the data cut off date of June 27, 2023, the median follow-up was 10.6 months for tarlatamab 10 mg and 10.3 months for tarlatamab 100 mg. The investigation revealed that, with a 10 mg dosage, there was a 40% objective response rate (ORR), with a median progression-free survival (mPFS) of 4.9 months, and a median overall survival (OS) of 14.3 months. The median duration of response was not reached.

Similarly, with a 100 mg dosage, the ORR was 32%, with a median PFS of 3.9 months, followed by a median OS that was NE. In terms of safety, the most common treatment-emergent adverse event was cytokine release syndrome, primarily occurring in cycle 1, and was mostly grade 1 or 2. The incidence of grade 3 CRS and grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) and associated neurologic events was low, with no grade 4 or 5 events. Overall, tarlatamab demonstrated a favorable safety profile, with a low rate of discontinuations due to TRAEs (3%).

DelveInsight estimates that the total incident population of SCLC in the US will reach ~40,000 in 2032. If approved, tarlatamab can compete with checkpoint inhibitors and grab a significant market share.

https://lh7-us.googleusercontent.com/ZU5S_SlzGFoMGKkbw_6wxp1XXS9mUbNKdWjyLk_e_jbPv3-zncNCh5ekYAfgnH_RLJfU3uHtQMayI9lo4YfbCDOaV6k6TuvMxPW7n2gE_A3V19jHkJrbtw7kQLdbUWKmalit7ZB8HuzD

Conclusion

Tarlatamab at 10 mg highlighted enduring anticancer efficacy alongside a manageable safety profile, affirming its potential utility in individuals with previously treated small cell lung cancer (SCLC). The current Phase III DeLLphi-304 study aims to evaluate further and compare the effectiveness and safety of tarlatamab (10 mg every 2 weeks) against standard-of-care chemotherapy, providing valuable insights into its broader therapeutic application.

Reference reports by DelveInsight for more in-depth analysis and key coverage - 

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Executive Summary

Tarlatamab at 10 mg reveals enduring anticancer efficacy with a well-managed safety profile. These findings endorse the utilization of tarlatamab in individuals with previously treated SCLC.

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