Checkpoint blockade plus taxanes-based chemotherapy yields diverse outcomes in first-line metastatic TNBC treatment. Toripalimab is a humanized IgG4K monoclonal antibody specific for PD-1 that provides significant clinical efficacy with a favorable safety profile in various solid tumors. As per the findings revealed at the ASCO 2023, at the data cutoff (November 30, 2022), around 531 patients were randomized to toripalimab who had PD-L1 positive TNBC. Based on the interim analysis, with a median follow-up of 14 months, the toripalimab arm exhibited statistically significant improvement in PFS, backed by BICR results. Moreover, the PD-L1 positive subgroup witnesses promising advancement with an extended mPFS of 8.4 months compared to 5.6 months. Apart from that, the descriptive analysis revealed a positive trend in overall survival for PD-L1 positive patients, with a notable increase in median OS of 32.8 months compared to 19.5 months. In terms of safety results, no new safety signals were identified. However, Grade≥3 adverse events (AEs) and fatal AEs showed comparable rates between arms (56.4% vs. 54.3% and 0.6% vs. 3.4%, respectively), while the toripalimab arm demonstrated a higher frequency of AEs leading to discontinuation (8.5% vs. 3.4%) and immune-related AEs (irAEs) (40.8% vs. 24.0%).
KOL insights
“The TNBC subtype of breast cancer is the most aggressive and has the worst prognosis.” –Expert Opinion.
Conclusion
Toripalimab provided a statistically significant and clinically meaningful improvement in PFS in combination with nab-p for PD-L1 positive metastatic or recurrent TNBC. Moreover, the combination also showed a trend towards improved overall survival. Throughout the study, the toripalimab combination with nab-p yielded great tolerability with no new safety signals to observe. At last, it can be concluded that the successful findings of the TORCHLIGHT trial could address the unmet medical needs and provide better treatment options after approval for the patients suffering from TNBC.
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