Neoadjuvant Opdivo (Nivolumab) Plus Chemotherapy Significantly Improves Event-Free Survival in Resectable Non-Small Cell Lung Cancer: Phase 3 CheckMate-816 Trial Success

News on November 10, 2021 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the Phase 3 CheckMate-816 trial has met itsResectable Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)The primary endpoint of improved event-free survival (EFS) in patients. A pre-specified interim analysis showed,When used for neoadjuvant (preoperative) treatment, compared with chemotherapy, the combination regimen of anti-PD-1 therapy Opdivo (nivolumab) and chemotherapy achieved statistically significant and clinically meaningful improvements in EFS.In the study, the safety of Opdivo + chemotherapy was consistent with previously reported NSCLC studies.

The results published in April this year showed,When used for neoadjuvant (preoperative) treatment, the Opdivo + chemotherapy regimen significantly improved pathological complete response (pCR) compared to chemotherapy alone.This is another primary endpoint of the study. pCR is defined as: no evidence of cancer cells in the excised tissue, as assessed by blinded independent pathological review. Specifically, compared with chemotherapy, three cycles of neoadjuvant treatment with Opdivo + chemotherapy significantly improved pCR:24% of patients who received Opdivo + chemotherapy before surgery achieved pCR, compared to only 2.2% in the chemotherapy group.(Odds Ratio [OR]=13.94, 99% CI: 3.49-55.75; p<0.0001). In addition, the Opdivo + chemotherapy regimen was well tolerated, with consistent improvement in pCR regardless of PD-L1 expression levels, histology, or disease stage. Meanwhile, the Opdivo + chemotherapy regimen also showed improvement in key secondary endpoints, including Major Pathological Response (MPR). The proportion of patients receiving Opdivo + chemotherapy who achieved MPR was four times that of the chemotherapy group (36.9% vs 8.9%; OR=5.70, 95% CI: 3.16-10.26). Achieving MPR indicatesTumorThe residual rate of cells is 10% or less.

It is worth mentioning in particular,CheckMate-816 represents the first randomized Phase 3 study showing that neoadjuvant immunotherapy combination treatment significantly improves event-free survival (EFS) and pathological complete response (pCR) in patients with resectable NSCLC.. As of now,Treatment regimens based on Opdivo have shown positive results in phase 3 trials for the early treatment of four different types of cancer, including: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer, andMelanoma。

Bristol-Myers Squibb will conduct a comprehensive evaluation of the data from the CheckMate-816 trial and plans to present it at an upcoming medical conference.MeetingPublish the results and submit them to the regulatory authorities.

French Curie ResearchTumorProfessor Nicolas Girard, Head of Internal Medicine, stated: "Although the aim of surgery is to cure resectable NSCLC, 30-55% of patients will experience postoperative recurrence and eventually die from the disease, making it critically necessary to explore other treatment options that may disrupt this progression."The positive event-free survival data from Opdivo + chemotherapy as neoadjuvant (pre-surgery) treatment is groundbreaking.", which is significant for how we treat resectable NSCLC."

Vice President of Bristol-Myers Squibb and ChestTumorAbderrahim Oukesou, M.D., Development Lead, stated: "CheckMate-816 is the first Phase 3Clinical Trial, showing that an immunotherapy combination used as neoadjuvant (pre-surgery) treatment for non-metastatic NSCLC has statistically significant and clinically meaningful therapeutic benefits. Opdivo + chemotherapy demonstrated for the first time a statistically significant improvement in pathological complete response (pCR) without impacting surgical outcomes, while extending patients' progression-free survival, delaying recurrence, and reducing mortality. These data reinforce the evidence that Opdivo-based regimens have the potential to improve long-term clinical outcomes when used in earlier stages of non-metastatic cancer."

Lung cancer is the leading cause of cancer death worldwide. The two main types of lung cancer are non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most common type of lung cancer, accounting for 84% of lung cancer diagnoses. Non-metastatic cases account for NSCLC.DiagnosisThe majority (approximately 60%). Although many patients with non-metastatic NSCLC are cured by surgery, 30%-55% of patients still experience recurrence and die from the disease after surgical resection. Therefore, treatment regimens are needed before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

Currently, in early-stage NSCLC, Bristol-Myers Squibb and its collaborators are exploring the application of immunotherapy in neoadjuvant treatment, adjuvant treatment, perioperative treatment, as well as in combination with chemoradiotherapy. The scientific rationale for using immunotherapy in the neoadjuvant setting has two aspects: (1) It provides the earliest opportunity to treat cancer cells that have spread undetected in the body (occult metastases); (2) The presence of a tumor during immunotherapy may elicit a stronger immune response, potentially enhancing the treatment’s effect on the primary tumor.TumorMore effective.

Opdivo belongs to PD-(L)1 tumor immunotherapy, which aims to use the body's own immune system to fight cancer by blocking the PD-1/PD-L1 signaling pathway to cause cancer cell death, having the potential to treat various types.Tumorpotential. As of now, Opdivo has been approved for various cancer indications.

In China, Opdivo was approved for marketing in June 2018, becoming the first immunotherapy drug approved in the Chinese market.Tumor(I-O) Therapeutic DrugsAs of now, Opdivo has been approved for multiple indications:

——In June 2018, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), and whose disease has progressed or become intolerable after previous chemotherapy containing platinum.

——In August 2019, for the treatment of patients who experienced disease progression during or after platinum-based therapy and whose tumors express PD-L1 (PD-L1 positive expression)TumorPatients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have ≥1% cells.

——In March 2020, it was approved for the treatment of patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have received two or more prior systemic therapy regimens.

——In June 2021, Opdivo in combination with Yervoy (Yiwo, Ipilimumab Injection) was approved for the treatment of adult patients with unresectable, previously untreated non-epithelioid malignant pleural mesothelioma. This is the first indication approved in China for the dual immunotherapy combination, marking the official launch of Yiwo, the world's first CTLA-4 inhibitor, in China.

——In August 2021, Opdivo in combination with fluorouracil and platinum-based chemotherapy was approved for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. This is the first immunotherapy in China.Tumor(I-O) drug approved for first-line treatment of advanced gastric cancer; Opdivo is also currently the only PD-1 inhibitor with a gastric cancer indication in China. (Bioon.com)

Source of the original text:Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Event-Free Survival in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial