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For patients with extensive-stage small cell lung cancer, Loqtorzi was shown to improve progression-free survival and overall survival.
Among patients with extensive-stage small cell lung cancer (ES-SCLC), the addition of Loqtorzi (toripalimab) to first-line chemotherapy was found to result in disease progression and survival benefits with what researchers described as an acceptable safety profile, making for a potential new treatment option for patients, according to recently published research.
Findings from the phase 3 EXTENTORCH study were published in JAMA Oncology.
“In this multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial, the addition of [Loqtorzi] to chemotherapy as a first-line treatment for patients with ES-SCLC significantly improved both [progression-free survival (PFS)] and [overall survival (OS)], while maintaining a tolerable safety profile,” researchers concluded in the study. “This combination regimen will provide a new first-line therapy option for this patient population.”
Extensive-stage small cell lung cancer: cancer that has spread throughout the lung to the other lung or to other parts of the body, according to the American Cancer Society.
Progression-free survival (PFS): the time a patient lives without their disease spreading or worsening.
Overall survival (OS): the time a patient lives, regardless of disease status.
Neutrophil: a type of white blood cell.
Anemia: lower levels of healthy red blood cells.
Loqtorzi, according to the National Cancer Institute, is an anti-PD-1 monoclonal antibody intended to restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
The trial, conducted at 49 sites in China, randomized 442 patients, with a median age of 63 and 82.8% male, with ES-SCLC who had not received previous systemic antitumor treatment for their disease. Patients received either 240 milligrams of Loqtorzi or placebo (inactive drug) plus etoposide and platinum-based chemotherapy (EP) every three weeks for up to four to six cycles. After, patients received maintenance therapy with Loqtorzi or placebo until they experienced disease progression, intolerable toxic effects or had been on treatment for up to two years, according to the study.
Researchers reported that patients treated with Loqtorzi had a 33% lower chance of disease progression or death, with a median PFS of 5.8 months in the Loqtorzi group and 5.6 months in the placebo group. The PFS rates were 47.1% versus 36.3% at six months and 18.1% versus 4.9% at one year, respectively.
Additionally, 174 of 223 patients (78%) died in the Loqtorzi group and 187 of 219 patients (85.4%) died in the placebo group, the study showed. Loqtorzi was associated with a 20% reduction in the risk of death. The median OS was 14.6 months in the Loqtorzi group and 13.3 months in the placebo group, with OS rates of 63.1% and 54.9% at one year and 25.9% and 19.5% at two years.
Nearly all patients participating in the study experienced side effects, including 99.5% of the Loqtorzi group and 100% of the placebo group experiencing treatment-emergent side effects, while grade 3 (severe) or higher treatment-emergent side effects were experienced by 89.6% and 89.4% of patients, respectively. Study treatment was discontinued due to treatment-emergent side effects for 12.6% and 7.9% of patients, respectively, with 12 patients in the Loqtorzi group and seven patients in the placebo group experiencing fatal treatment-emergent side effects.
The most common side effects were decreased neutrophil count (any grade 91%, grade 3 or higher 74.3% in the Loqtorzi group versus 88.4% and 75% in the placebo group), decreased white blood cell count (90.1% and 38.7% versus 89.8% and 44.9%), anemia (89.6% and 30.6% versus 91.2% and 34.7%) and decreased platelet count (66.7% and 24.8% versus 72.2% and 34.3%).
“Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial” by Dr. Ying Cheng et al., JAMA Oncology.
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