PRINCETON -
The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.1 This application was reviewed under the
Approval for Opdivo + Yervoy with limited chemotherapy is based on the pre-specified interim analysis from the Phase 3 CheckMate -9LA trial in which Opdivo + Yervoy combined with two cycles of platinum-doublet chemotherapy demonstrated superior overall survival (OS) versus chemotherapy (hazard ratio [HR] 0.69; 96.71% confidence interval [CI]: 0.55 to 0.87; P=0.0006) regardless of PD-L1 expression or tumor histology (minimum 8.1 months follow up).1,3 Median overall survival (mOS) was 14.1 months (95% CI: 13.2 to 16.2) versus 10.7 months (95% CI: 9.5 to 12.5), respectively.1 In a follow-up analysis at 12.7 months, the hazard ratio improved numerically to 0.66 (95% CI: 0.55 to 0.80), with mOS of 15.6 months (95% CI: 13.9 to 20.0) and 10.9 months (95% CI: 9.5 to 12.5).1,3 At one year, 63% of patients treated with Opdivo + Yervoy with limited chemotherapy and 47% of those treated with chemotherapy were still alive.3
Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion-related reactions; embryo-fetal toxicity and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1,4
'We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients' long-term outcomes,' said
In the trial, the overall response rate (ORR) per Blinded Independent Central Review (BICR) was 38% (95% CI: 33 to 43) for patients treated with Opdivo + Yervoy with limited chemotherapy and 25% (95% CI: 21 to 30) for patients treated with chemotherapy.
'Non-small cell lung cancer is a complex disease that requires multiple treatment options to address the needs of different patient populations,'5 said
Opdivo + Yervoy is a unique combination of immune checkpoint inhibitors, featuring a potentially synergistic mechanism of action that targets two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.1,4,6 Some of the T cells stimulated by Yervoy can become memory T cells, which may allow for a long-term immune response.6,7,8,9,10,11 Targeting of normal cells can also occur and result in immune-mediated adverse reactions, which can be severe and potentially fatal.1
'Receiving a diagnosis of advanced lung cancer is devastating,'12 said
This application is part of the
About CheckMate -9LA
CheckMate -9LA (NCT03215706) is a Phase 3, randomized open-label, multi-center study evaluating Opdivo + Yervoy combined with two cycles of platinum-doublet chemotherapy versus platinum-doublet chemotherapy (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic or recurrent NSCLC regardless of PD-L1 expression and histology.1 A total of 361 patients were treated with Opdivo + Yervoy with platinum-doublet chemotherapy until disease progression, unacceptable toxicity or for up to two years.1 A total of 358 patients were treated with platinum-doublet chemotherapy for four cycles and optional pemetrexed maintenance for non-squamous patients (if eligible) until disease progression or toxicity.1 The primary efficacy outcome measure of the trial was OS.1 Additional efficacy outcome measures included progression-free survival, ORR and duration of response as assessed by BICR.1
Select Safety Profile from CheckMate -9LA Study
Serious adverse reactions occurred in 57% of patients.1 Opdivo + Yervoy in combination with platinum-doublet chemotherapy were discontinued for adverse reactions in 24% of patients and 56% had at least one treatment withheld for an adverse reaction.1 The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis and respiratory failure.1 Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia and massive hemoptysis in the setting of thrombocytopenia.1 The most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%) and pruritus (21%).1
About
Lung cancer is the leading cause of cancer death in the United States.12 The two main types of lung cancer are non-small cell and small cell.13 Non-small cell lung cancer is one of the most common types of lung cancer, and accounts for approximately 84% of diagnoses.13 Survival rates vary depending on the stage and type of the cancer when diagnosed.12
About
BMS Access Support, the
About the
In 2011, through a collaboration agreement with
About
Celgene and
Cautionary Statement Regarding Forward-Looking Statements
This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, whether Opdivo in combination with Yervoy for the additional indication described in this release will be commercially successful and that continued approval of such combination treatment for such additional indication described in this release may be contingent upon verification and description of clinical benefit in confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect
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