Findings from the phase 3 Neotorch trial indicate that toripalimab plus chemotherapy has met the primary end point of event-free survival among patients with operable non–small cell lung cancer.
Perioperative toripalimab (Tuoyi) in combination with platinum-containing doublet chemotherapy achieved a primary end point of event-free survival (EFS) in patients with operable non–small cell lung cancer (NSCLC), according to a press release on data from a pre-specified interim analysis of the phase 3 Neotorch trial (NCT04158440).
An independent data monitoring committee determined that perioperative toripalimab plus chemotherapy and single-agent toripalimab as consolidation therapy thereafter may significantly extend the EFS of patients with NSCLC compared with chemotherapy alone. Based on the data, the toripalimab’s manufacturers will communicate with regulatory authorities about submitting a supplemental new drug application in the future.
The safety data of toripalimab in the Neotorch trial was consistent with those previously reported for the agent, and investigators identified no new safety signals.
The randomized, double-blind, placebo-controlled, multi-center phase 3 Neotorch trial assessed the safety and efficacy of toripalimab plus platinum-containing doublet chemotherapy compared with placebo plus chemotherapy for operable NSCLC. Investigators conducted the study across 56 centers nationwide.
In the experimental arm, patients received 240 mg of toripalimab intravenously combined with a chemotherapy regimen consisting of cisplatin, carboplatin, pemetrexed, paclitaxel, and docetaxel for 4 cycles during the perioperative period and then 240 mg of consolidation toripalimab intravenously after surgery. Patients in the comparator arm received matched placebo along with the same chemotherapy backbone followed by placebo consolidation therapy after surgery.
Another primary end point of the trial was major pathological remission rate as assessed by a blind independent pathology review committee (BIPR). Secondary end points included pathological complete remission rate as assessed by BIPR, EFS per independent review committee, disease-free survival, overall survival, and safety.
Patients 18 to 70 years old with treatment-naïve; histologically confirmed; resectable stage II, IIIA, or IIIB NSCLC were eligible to enroll on the Neotorch trial.
Additional inclusion criteria included having measurable lesions per RECIST v1.1 criteria, tumor tissue specimens available for pathological diagnosis and detection of PD-L1 expression prior to treatment randomization, an ECOG performance status of 0 or 1, adequate organ function, and a pulmonary function test being able to withstand the planned pneumonectomy as evaluated by surgeons.
Patients with presence of locally advanced, unresectable, or metastatic disease or NSCLC involving a superior sulcus, large cell neuroendocrine carcinoma sarcomatoid tumor were unable to enroll on the trial. Patients were also unable to enroll if they had known EGFR mutations or ALK translocations, previous treatment with systemic therapy for NSCLC, active tuberculosis, active infection requiring systemic treatment, uncontrolled active hepatitis B, or known human immunodeficiency virus infection.
Additionally, patients were unsuitable for enrollment if they had grade 2 or more peripheral neuropathy, previous treatment with PD-L1 agents, a severe allergic reaction to monoclonal antibodies, or other malignant tumors within 5 years prior to the first study dose.
Junshi Biosciences announces toripalimab as perioperative treatment for operable NSCLC patients met primary endpoint in phase 3 clinical study. News release. Junshi Biosciences. January 17, 2023. Accessed January 18, 2023. yhoo.it/3IX7l0p