Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability?High Me
Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the?Opdivo?plus?Yervoy?combination with durable responses observed
Opdivo?plus?Yervoy?is the first dual immunotherapy regimen approved in the European Union for colorectal cancer
Opdivo?plus?Yervoy-based combinations now indicated in the European Union for five different advanced cancer types: mesothelioma, non-small cell lung cancer, melanoma, renal cell carcinoma and colorectal cancer
PRINCETON, N.J.--(BUSINESS WIRE)--?Bristol Myers Squibb?(NYSE: BMY) announced that the European Commission (EC) has approved?Opdivo?(nivolumab) plus?Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy. The EC?s decision is based on results from the Phase 2 CheckMate -142 trial in which?Opdivo?plus?Yervoy?demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. The safety profile for?Opdivo?plus?Yervoy?was consistent with previous studies of the combination in other tumor types.
?Metastatic colorectal cancer is an aggressive disease with a poor prognosis, leaving patients with a critical need for additional treatment options beyond standard chemotherapy,? said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. ?With this approval, patients in the EU with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer will now have the first dual immunotherapy treatment available to them, and we look forward to working with stakeholders to advance this rational combination.?
The combination of?Opdivo?plus?Yervoy?is the first approved dual immunotherapy treatment option for any GI tumor in the European Union (EU). This combination is also approved in the EU for non-small cell lung cancer and renal cell carcinoma. The Marketing Authorization approves use of?Opdivo?plus?Yervoy?in all EU member states, as well as Norway, Iceland and Liechtenstein.
Opdivo?plus?Yervoy?received?approval?from the U.S. Food and Drug Administration (FDA) in July 2018 for the treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.?Opdivo?plus?Yervoy?was also approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in September 2020 for the treatment of MSI-H unresectable advanced or recurrent colorectal cancer progressing after cancer chemotherapy.
CheckMate -142 Efficacy and Safety Results
Results from the CheckMate -142 trial at minimum follow-up of 46.9 months include:
- ORR:?In the study, 64.7% (95% Confidence Interval: 55.4 to 73.2) of patients responded to treatment with?Opdivo?plus?Yervoy, with 12.6% achieving a complete response.
- DOR:?Median duration of response was not reached in the?Opdivoplus?Yervoyarm (1.4, 58.0+ months).
- Safety: The most frequent adverse reactions, occurring in 10% or more of patients treated with?Opdivo?plus?Yervoy, were fatigue (58%), diarrhea (41%), musculoskeletal pain (39%), rash (38%), pruritus (35%), nausea (30%), cough (29%), pyrexia (29%), abdominal pain (22%), arthralgia (22%), decreased appetite (22%), upper respiratory tract infection (21%), vomiting (21%), headache (19%), dyspnoea (19%), hypothyroidism (18%), constipation (18%), oedema (including peripheral oedema) (16%), dizziness (14%), hyperthyroidism (12%), dry skin (11%), hypertension (10%). The majority of adverse reactions were mild to moderate (Grade 1 or 2).