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Adding toripalimab to nab-paclitaxel improves progression-free survival (PFS) in patients with PD-L1-positive metastatic or recurrent triple-negative breast cancer (TNBC), according to research presented at the ASCO Annual Meeting 2023.
Results from the phase 3 TORCHLIGHT trial showed a “statistically significant and clinically meaningful” improvement in PFS for patients with PD-L1-positive TNBC, as well as a “promising trend” toward improvement in overall survival (OS), said study presenter Qiang Liu, MD, PhD, of Sun Yat-sen Memorial Hospital in Guangzhou, China.
The TORCHLIGHT trial (ClinicalTrials.gov Identifier: NCT04085276) included 528 patients who had TNBC that was initially diagnosed as stage IV or was recurrent and inoperable.
The patients were randomly assigned 2:1 to receive toripalimab (n=353) or placebo (n=178) in addition to nab-paclitaxel. Baseline characteristics were well balanced between the arms. Patients with PD-L1-positive disease made up most of the toripalimab arm (n=200) and the placebo arm (n=100).
Patients in the toripalimab arm received the drug at 240 mg on day 1 of every 3-week cycle. In both arms, nab-paclitaxel was given at 125 mg/m2 on days 1 and 8 of each cycle. Patients continued on treatment until disease progression or intolerable toxicity.
The median follow-up was 14 months. There was a significant improvement in PFS with toripalimab in the PD-L1-positive population, but significance was not reached in the overall population.
In the overall population, the median PFS was 8.4 months in the toripalimab arm and 6.9 months in the placebo arm (hazard ratio [HR], 0.77; 95% CI, 0.60-0.99; P =.0445). The 1-year PFS rate was 41.1% in the toripalimab arm and 29.8% in the placebo arm. The 2-year PFS rate was 20.5% and 11.3%, respectively.
Among PD-L1-positive patients, the median PFS was 8.4 months in the toripalimab arm and 5.6 months in the placebo arm (HR, 0.65; 95% CI, 0.47-0.91; P =.0102). The 1-year PFS rate was 41.9% in the toripalimab arm and 24.4% in the placebo arm. The 2-year PFS rate was 23.5% and 14.5%, respectively.
A descriptive OS analysis showed a trend toward improvement in OS with toripalimab in the PD-L1-positive patients and in the overall population.
In the overall population, the median OS was 33.1 months in the toripalimab arm and 23.5 months in the placebo arm (HR, 0.69; 95% CI, 0.51-0.93; P =.0145). The 1-year OS rate was 81.0% in the toripalimab arm and 77.6% in the placebo arm. The 2-year OS rate was 61.0% and 47.2%, respectively. The 3-year OS rate was 48.4% and 32.1%, respectively.
Among PD-L1-positive patients, the median OS was 32.8 months in the toripalimab arm and 19.5 months in the placebo arm (HR, 0.62; 95% CI, 0.41-0.91; P =.0148). The 1-year OS rate was 82.6% in the toripalimab arm and 73.0% in the placebo arm. The 2-year OS rate was 64.6% and 43.5%, respectively. The 3-year OS rate was 47.9% and 33.0%, respectively.
No new safety signals were identified, Dr Liu said. The most common adverse events in both arms were decreases in white blood cells, decreases in neutrophils, alopecia, and anemia. Hypothyroidism, hyperthyroidism, rash, aspartate aminotransferase increase, alanine transaminase increase, asthenia, pneumonitis, and nausea were all more common in the toripalimab arm than in the placebo arm.
Disclosures: This research was supported by Shanghai Junshi Biosciences Co, Ltd. The study authors declared no conflicts of interest, but Dr Liu disclosed relationships with Novartis, AstraZeneca, Pfizer, Roche, and Eisai.
Reference
Jiang Z, Ouyang Q, Sun T, et al. TORCHLIGHT: A randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel (nab-P) for patients with metastatic or recurrent triple-negative breast cancer (TNBC). ASCO 2023. June 2-6, 2023. Abstract LBA1013.
