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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Health Canada Approves OPDIVO (nivolumab) plus YERVOY (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

Published date:
06/02/2021
Excerpt:
Today, Bristol Myers Squibb Canada (BMS) announced Health Canada’s approval of OPDIVO (nivolumab) 360 mg every three weeks or 3mg/kg every two weeks plus YERVOY (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.
Trial ID:
Evidence Level:
Sensitive: A1 - Approval
Title:

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma

Published date:
06/02/2021
Excerpt:
Bristol Myers Squibb...announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
Trial ID:
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
12/29/2020
Excerpt:
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of…adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
...the NCCN panel recommends the following subsequent immunotherapy options for patients with MPM:…2) nivolumab with (or without) ipilimumab…
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

Malignant pleural mesothelioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Excerpt:
Recommendations...First-line systemic therapy...Nivolumab plus ipilimumab, given up to 2 years equivalent dosing, is recommended as a first-line systemic therapy option regardless of histologies or PD-L1 status for unresectable MPM [I, A; ESMO-MCBS v1.1 score: 3]
DOI:
https://doi.org/10.1016/j.annonc.2021.11.005
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743

Published date:
02/02/2022
Excerpt:
...nivolumab plus ipilimumab continued to prolong OS versus chemotherapy. Median OS was 18.1 versus 14.1 months (HR [95% CI], 0.73 [0.61–0.87]), and 3-year OS rates were 23% versus 15%, respectively. Three-year progression-free survival rates were 14% versus 1%, and objective response rates were 40% versus 44%. At 3 years, 28% versus 0% of responders had an ongoing response. Improved survival benefit with nivolumab plus ipilimumab versus chemotherapy was observed across subgroups...
DOI:
https://www.annalsofoncology.org/article/S0923-7534(22)00083-7/fulltext
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma

Published date:
04/23/2021
Excerpt:
Bristol Myers Squibb...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM)...The positive CHMP opinion is based on results from CheckMate -743, the first and only positive Phase 3 immunotherapy trial in first-line MPM. The trial met the primary endpoint of superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients.
Secondary therapy:
pemetrexed + carboplatin; cisplatin + pemetrexed
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial

Published date:
01/21/2021
Excerpt:
At the prespecified interim analysis...nivolumab plus ipilimumab significantly extended overall survival versus chemotherapy...2-year overall survival rates were 41% (95% CI 35·1–46·5) in the nivolumab plus ipilimumab group and 27% (21·9–32·4) in the chemotherapy group....Nivolumab plus ipilimumab provided significant and clinically meaningful improvements in overall survival versus standard-of-care chemotherapy...
DOI:
https://doi.org/10.1016/S0140-6736(20)32714-8
Trial ID: