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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) + Yervoy (ipilimumab) (CTLA4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Opdivo® (Nivolumab) Intravenous Infusion Approved for First–Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer in South Korea
Published date:
12/17/2020
Excerpt:
Ono Pharmaceutical Co., Ltd.... a Korean subsidiary of ONO, received approval of Opdivo® (generic name: niolumab)...from the Ministry of Food and Drug Safety (MFDS) in South Korea, for the first-line treatment of unresectable, advanced or recurrent non-small cell lung cancer, in the following combination therapies...Combination therapy with Opdivo, Yervoy plus platinum-based chemotherapy.
Secondary therapy:
Chemotherapy
Trial ID:
Source:
Published date:
11/06/2020
Excerpt:
Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
Secondary therapy:
Chemotherapy
Source:
Title:
Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer
Published date:
08/11/2020
Excerpt:
MONTREAL, Aug. 11, 2020 /CNW/ - Today, Bristol Myers Squibb Canada (BMS) announces Health Canada's approval of OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) with two cycles of platinum-double chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tumour aberrations and no prior systemic therapy for metastatic NSCLC.
Secondary therapy:
Chemotherapy
Source:
Excerpt:
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of...adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.
Secondary therapy:
Chemotherapy
Source:
Title:
Nivolumab with ipilimumab and chemotherapy for untreated metastatic nonsmall-cell lung cancer
Published date:
09/08/2021
Excerpt:
Nivolumab plus ipilimumab and 2 cycles of platinum-doublet chemotherapy is not recommended, within its marketing authorisation, for untreated metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations
Source:
Published date:
02/16/2021
Excerpt:
Adenocarcinoma, large cell, NSCLC NOS…Other recommended…Nivolumab/ipilimumab/pemetrexed/(carboplatin or cisplatin)
Secondary therapy:
cisplatin + pemetrexed; carboplatin + pemetrexed
Source:
Excerpt:
Nivolumab/ipilimumab is recommended for patients with metastatic NSCLC, regardless of PD-L1 levels or histology...
Source:
Title:
1261O - Neoadjuvant nivolumab (N) + ipilimumab (I) vs chemotherapy (C) in the phase III CheckMate 816 trial
Published date:
10/16/2023
Excerpt:
These exploratory analyses from CheckMate 816 showed potential clinical benefit and a manageable safety profile with neoadjuvant N + I vs C; N + C remains the standard neoadjuvant treatment for pts with resectable NSCLC, as previously reported.
Trial ID:
Source:
Title:
First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817
Published date:
02/01/2023
Excerpt:
CheckMate 817, a phase 3B study, evaluated flat-dose nivolumab plus weight-based ipilimumab in patients with metastatic non-small cell lung cancer (NSCLC)…. Flat-dose nivolumab plus weight-based ipilimumab was associated with manageable safety and durable efficacy in cohort A, consistent with data from phase 3 metastatic NSCLC studies.
DOI:
http://dx.doi.org/10.1136/jitc-2022-006127
Trial ID:
Source:
Title:
Randomized phase III study of nivolumab and ipilimumab versus carboplatin-based doublet in first-line treatment of PS 2 or elderly (≥ 70 years) patients with advanced non–small cell lung cancer (Energy-GFPC 06-2015 study)
Published date:
05/26/2022
Excerpt:
The subgroup analyses showed a significant benefit of the association N-I compared to CT for elderly PS 0/1 patients, with median OS of 22.6 (95% CI, 18.1-36) vs. 11.8 (95% CI, 8.9-20.5) months, p = 0.02. In PS2 patients, median OS of N-I and CT arms was 2.9 (1.4-4.8) vs. 6.1 (3.5-10.4) months (p = 0.22). Median PFS was significantly in favor of N-I arm in the entire population: 5.5 (2.8-8.7) vs. 4.6 (3.5-5.6); p = 0.015...there was a clinical signal of efficacy of N-I combination over platinum doublet in elderly NSCLC patients PS 0-1 with a significant benefit of OS of 22.6 months vs. 11.8 for CT arm.
DOI:
10.1200/JCO.2022.40.16_suppl.9011
Trial ID:
Source:
Title:
First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update
Published date:
10/01/2021
Excerpt:
With a 2-year minimum follow-up, nivolumab plus ipilimumab with two cycles of chemotherapy provided durable efficacy benefits over chemotherapy with a manageable safety profile and remains an efficacious first-line treatment of advanced non-small-cell lung cancer.
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.esmoop.2021.100273
Trial ID:
Source:
Title:
First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial
Published date:
01/18/2021
Excerpt:
...1150 patients were enrolled and 719 (62·5%) randomly assigned to nivolumab plus ipilimumab with two cycles of chemotherapy (n=361 [50%]) or four cycles of chemotherapy alone (n=358 [50%]). At the pre-planned interim analysis (median follow-up 9·7 months [IQR 6·4–12·8]), overall survival in all randomly assigned patients was significantly longer in the experimental group than in the control group...Nivolumab plus ipilimumab with two cycles of chemotherapy provided a significant improvement in overall survival versus chemotherapy alone...
Secondary therapy:
Chemotherapy
DOI:
10.1016/S1470-2045(20)30641-0
Trial ID:
Title:
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
Published date:
09/18/2020
Excerpt:
...Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have no sensitizing EGFR mutation or ALK translocation....The CHMP adopted the positive opinion based on results from the Phase 3 CheckMate -9LA trial...
Secondary therapy:
Chemotherapy
