To evaluate the safety and clinical efficacy of sapanisertib, a next-generation mTOR inhibitor, in patients with advanced anaplastic thyroid carcinoma (ATC) and radioiodine-refractory differentiated thyroid carcinoma (DTC), specifically focusing on those who have exhausted other treatment options.
Key Findings:
11% of ATC patients were progression-free at 4 months; 22.2% had stable disease, indicating limited efficacy.
Enrollment in the ATC cohort was stopped early due to futility, raising concerns about the drug's effectiveness.
1 confirmed partial response (4.5%) in RAIR DTC, with 63.6% having stable disease, suggesting minimal impact.
Median progression-free survival was 1.6 months for ATC and 7.8 months for DTC, highlighting the need for better treatment options.
Sapanisertib monotherapy did not meet the primary endpoint in ATC and showed limited clinical activity, indicating a need for alternative therapeutic strategies and further research into more effective treatments.
Limitations:
Small sample size with early termination of the ATC cohort, which limits the generalizability of the findings.
Limited efficacy observed in both ATC and RAIR DTC, suggesting the need for more robust clinical trials.
Conclusion:
Sapanisertib did not demonstrate clinically meaningful activity in advanced ATC or RAIR DTC, highlighting the urgent need for further clinical trials with different therapeutic approaches to improve patient outcomes.
by Kartik Sehgal, Anthony Serritella, Mofei Liu, Anne ONeill, Chaitali Nangia, Theodora Pappa, Michael J Demeure, Francis P Worden, Robert I Haddad, Jochen Lorch
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