Immunotherapy Reduces Lung Cancer Recurrence Risk by 34%; Janssen/Legend Biotech CAR-T Therapy Shows Over 95% Response Rate

The American Society of Clinical Oncology (ASCO) Annual Meeting will be held online from June 4 to June 8 this year. As one of the largest annual clinical oncology conferences, the ASCO Annual Meeting has consistently served as a platform for numerous biopharmaceutical and biotechnology companies to present their latest clinical research findings.

Roche's Blockbuster PD-L1 Inhibitor Significantly Extends "Cancer-Free Survival" in Early-Stage Lung Cancer Patients

Lung cancer is one of the leading causes of cancer-related mortality worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all lung cancer cases. Consequently, the development of therapies targeting NSCLC has remained a major focus in oncology drug development. In the treatment of NSCLC, cancer immunotherapies represented by PD-1/PD-L1 inhibitors have been approved for the first-line treatment of metastatic NSCLC. Expanding the application of immunotherapy to patients with earlier-stage disease to improve the potential for cure represents one of the key directions in immunotherapy research and development.

On May 20, Roche announced that its leading PD-L1 inhibitor Tecentriq achieved positive results in a pivotal Phase 3 clinical trial evaluating its use as adjuvant therapy for patients with early-stage NSCLC. Compared with best supportive care, Tecentriq as adjuvant therapy reduced the risk of disease recurrence or death by 34% (HR=0.66, 95% CI: 0.50–0.88) in patients with stage II–IIIA NSCLC and tumor PD-L1 expression >1%. These patients had previously undergone surgical resection and adjuvant chemotherapy. In this patient population, the median disease-free survival (DFS) for patients receiving adjuvant Tecentriq was not reached, compared with a median DFS of 35.3 months in the best supportive care group.

This is the first positive Phase 3 clinical trial result for a cancer immunotherapy as an adjuvant therapy for lung cancer.

In a broader population of patients with stage II-IIIA NSCLC (regardless of PD-L1 expression status), Tecentriq reduced the risk of disease recurrence or death by 21% (HR=0.79, 95% CI: 0.64-0.96). In this patient population, Tecentriq extended DFS by nearly 7 months.

“These milestone Phase 3 data demonstrate for the first time that cancer immunotherapy can deliver clinically meaningful improvements for certain patients with early-stage lung cancer in the adjuvant setting,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “They lay the foundation for a new approach to treating early-stage lung cancer.”

Response Rate Exceeds 95%, Janssen/Legend Biotech CAR-T Therapy Demonstrates Excellent Efficacy Across Multiple Patient Populations

Ciltacabtagene autoleucel (cilta-cel), a CAR-T therapy co-developed by Janssen and Legend Biotech, is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It features a unique chimeric antigen receptor structure that incorporates two BCMA-targeting single-domain antibodies. Recently, the two companies have submitted marketing authorization applications for this CAR-T therapy to the U.S. FDA and the European EMA.

The ASCO abstract shows that in the Phase 1b/2 CARTITUDE-1 clinical trial, 97 patients with relapsed/refractory multiple myeloma (R/R MM) who had received a median of 6 prior lines of therapy received a single infusion of cilta-cel. At a median follow-up of 12.4 months, cilta-cel achieved an overall response rate of 97%, with 67% of patients achieving a stringent complete response (sCR); the median duration of response had not been reached. The 12-month progression-free survival rate and overall survival rate were 77% and 89%, respectively, and the median progression-free survival had not been reached.

Currently, CAR-T therapy is typically used to treat patients with refractory MM who have exhausted other treatment options. In the Phase 2 CARTITUDE-2 clinical trial, cilta-cel was used to treat patients with earlier-stage MM, among whom those in Cohort A had experienced disease progression after only 1 to 3 prior lines of therapy.

Trial results showed that at a median follow-up of 5.8 months, 95% of the 20 treated patients achieved a response, of whom 75% achieved a stringent complete response. Among the 4 patients evaluable for minimal residual disease (MRD) testing, all achieved MRD-negative status.

Note: The original text has been abridged.

References:

[1] Pivotal Phase III data at ASCO show Roche’s Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning. Retrieved May 20, 2021, from https://www.roche.com/media/releases/med-cor-2021-05-20.htm

[2] KEYNOTE-799: Phase 2 trial of pembrolizumab plus platinum chemotherapy and radiotherapy for unresectable, locally advanced, stage 3 NSCLC. Retrieved May 20, 2021, from https://meetinglibrary.asco.org/record/196541/abstract

[3] Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1.Retrieved May 20, 2021, from https://meetinglibrary.asco.org/record/195437/abstract

[4] CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after one to three prior lines of therapy. Retrieved May 20, 2021, fromhttps://meetinglibrary.asco.org/record/195446/abstract

[5] Allogene Therapeutics CD19 Forum Highlights Positive Results from Phase 1 Studies of ALLO-501 and ALLO-501A in Relapsed/Refractory Non-Hodgkin Lymphoma and Plan to Initiate Pivotal Study in 2021. Retrieved May 20, 2021, from https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-cd19-forum-highlights-positive-results

[6] With new data, J&J’s CAR-T drug benefits myeloma patients with less advanced disease. Retrieved May 20, 2021, from https://www.statnews.com/2021/05/19/with-new-data-jjs-car-t-drug-benefits-myeloma-patients-with-less-advanced-disease/

Note: This article is intended to present advances in medical and health research and does not constitute a treatment recommendation. For guidance on treatment options, please consult a licensed healthcare professional at a qualified medical institution.

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