BMS Announces Two-Year Survival Rate of 38% with Opdivo + Yervoy and Limited Chemotherapy as First-Line Treatment for Advanced NSCLC in CheckMate-9LA Trial

May 24, 2021 /BioonBIOON/ -- Bristol-Myers Squibb (BMS) recently announced the latest data from the Phase 3 CheckMate-9LA study evaluating the combination of anti-PD-1 therapy Opdivo (nivolumab), anti-CTLA-4 therapy Yervoy (ipilimumab), and platinum-doublet chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC).

The results showed that, after 2 years of follow-up, compared with 4 cycles of chemotherapy alone, the Opdivo + Yervoy + 2 cycles of chemotherapy regimen demonstrated a durable survival benefit,Sustained improvement in overall survival (OS) and progression-free survival (PFS), and prolonged duration of response (DOR). Specifically, this dual immunotherapy-based combination therapy regimen, inClinical benefit demonstrated in key patient subgroups，Regardless of PD-L1 expression level or histology.

Martin Reck, MD, CheckMate-9LA investigator at the Lung Clinic Grosshansdorf, German Center for Lung Research, stated: “Despite considerable advances in the treatment of advanced non-small cell lung cancer, most patients still do not achieve long-term survival. The objective of the CheckMate-9LA trial was to combine the durable benefits demonstrated with Opdivo + Yervoy dual immunotherapy in other Phase 3 trials with short-course chemotherapy to help achieve early cancer control. Now, with two years of follow-up, we continue to see the promise of this approach; compared with chemotherapy alone, patients receiving Opdivo + Yervoy plus a limited course of chemotherapy demonstrated sustained survival improvement.”

Opdivo+Yervoy (OY combination) is the first and only regulatory-approved dual immunotherapy.Opdivo + Yervoy is a unique combination of two immune checkpoint inhibitors with a potential synergistic mechanism of action, targeting two distinct checkpoints (PD-1 and CTLA-4) and functioning in a complementary manner to help the body destroyTumorCells. To date, the Opdivo + Yervoy combination therapy has been approved for 7 treatment indications across 6 types of cancer (`Melanoma`, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma).

To date,Opdivo + Yervoy Combination Therapy in 6 Phase IIIClinical Trialshowed a significant improvement in overall survival (OS): Non-small cell lung cancer (CheckMate-227, CheckMate-9LA), metastaticMelanoma(CheckMate-067), advanced renal cell carcinoma (CheckMate-214), malignant pleural mesothelioma (CheckMate-743), esophageal squamous cell carcinoma (CheckMate-648).

Vice President of Bristol-Myers Squibb and ThoracicTumorHead of Development Abderrahim Oukesou, M.D., stated: “Our research on metastatic cancer aims to further improve survival rates and help patients diagnosed with advanced non-small cell lung cancer and other cancers live longer. At this year's ASCOConference..., we will present data from multiple Phase 3Clinical Trialresults, these trials demonstrated the significant durability of Opdivo in combination with Yervoy across various types of cancer. We are encouraged that data from CheckMate-9LA show that this unique treatment approach continues to demonstrate significant benefit in the first-line treatment of advanced non-small cell lung cancer at the 2-year follow-up.”

CheckMate-9LA is a global, multicenter, randomized, open-label study conducted in collaboration with Ono Pharmaceutical and Bristol-Myers Squibb, evaluating the combination regimen of Opdivo + Yervoy + platinum-doublet chemotherapy (2 cycles) versus platinum-doublet chemotherapy alone as first-line treatment for patients with unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC), regardless of PD-L1 expression and histology. In the study, the experimental arm received Opdivo (360 mg every 3 weeks [Q3W]) + Yervoy (1 mg/kg every 6 weeks [Q6W]) + chemotherapy (2 cycles) for up to 2 years, or until disease progression or unacceptable toxicity. The control arm received chemotherapy (up to 4 cycles) followed by optional pemetrexed maintenance therapy (if eligible), continued until disease progression or toxicity. The primary endpoint was overall survival (OS) in the intent-to-treat (ITT) population, and secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and according toBiomarkerevaluation of therapeutic efficacy.

The newly announced 2-year follow-up results show that: among patients receiving Opdivo + Yervoy plus 2 cycles of chemotherapy,At 2 years, 38% of patients were still alive., but onlyAmong patients receiving chemotherapy, this rate was only 26%.. Furthermore, regarding the primary endpoint of overall survival (OS), the median OS in the two groups was 15.8 months (Opdivo + Yervoy + 2 cycles of chemotherapy group) and 11.0 months (chemotherapy group), respectively (HR = 0.72, 95% CI: 0.61–0.86).

With extended follow-up, the Opdivo + Yervoy + 2-cycle chemotherapy regimen demonstratesClinically Meaningful Therapeutic Benefits Maintained Across All Key Subgroups, including: PD-L1 expression <1% and ≥1%, squamous and non-squamous histology, central nervous system metastases.

Additionally, the Opdivo + Yervoy + 2-cycle chemotherapy regimen inSustained improvement was demonstrated in secondary endpoints (including progression-free survival [PFS] and overall response rate [ORR]) and exploratory endpoints (such as duration of response [DoR]).: (1) In terms of PFS, at 2 years, the Opdivo + Yervoy + 2 cycles of chemotherapy regimen reduced the risk of disease progression or death by 33% compared with chemotherapy alone (HR: 0.67; 95% CI: 0.56–0.79). (2) In terms of ORR, the Opdivo + Yervoy + 2 cycles of chemotherapy regimen demonstrated a higher proportion of patients achieving disease response compared with chemotherapy alone (38% vs. 25%). (3) In terms of DoR, the DoR for the Opdivo + Yervoy + 2 cycles of chemotherapy regimen increased to 13.0 months, compared with 5.6 months for chemotherapy alone.

With further follow-up, no new safety signals or treatment-related deaths were observed. Among patients receiving Opdivo + Yervoy plus 2 cycles of chemotherapy, 48% experienced Grade 3 or 4 treatment-related adverse events, compared to 38% among patients receiving chemotherapy alone. (Bioon.com)

Source: Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy Demonstrates Durable Overall Survival vs. Chemotherapy at Two Years in First-Line Non-Small Cell Lung Cancer in Phase 3 CheckMate -9LA Trial