“The combination of the programmed death receptor 1 (PD-1) inhibitor nivolumab at a reduced dose (1 mg/kg) with the cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor ipilimumab at standard dose (3 mg/kg) for four doses followed by standard-dose nivolumab alone is a standard of care for patients with advanced, previously untreated melanoma. This is based on results from the phase III CheckMate-067 trial that confirmed combination therapy is significantly more effective than single-agent nivolumab or ipilimumab. However, improvement in efficacy is associated with increased treatment-related grade 3/4 adverse events and treatment discontinuation in nearly 40% of patients.”
“Matthew D. Hellmann, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the CheckMate-032 study, which explored nivolumab (Opdivo) with or without ipilimumab (Yervoy) for patients with small cell lung cancer (SCLC).”
“Bristol-Myers got a much-needed boost with the earlier-than-expected news that Opdivo beat out Yervoy in a Phase III study focused on a particular niche for adjuvant melanoma therapy. And an analyst who’s been following the data says it could be worth a billion dollars in added annual sales.
“The big biotech says an interim analysis of Checkmate-238 provided researchers with proof that the PD-1 drug outperformed Yervoy, Bristol-Myers’ CTLA-4 drug, among advanced Stage IIIb or IV patients, cutting the recurrence rate for those who have undergone surgery. There are no bottom line numbers in the statement, but Bristol-Myers says they’ll be able to release data at an upcoming conference to show that Opdivo provided a significantly lower risk of disease recurrence.”
There are many hopes that combining immune checkpoint inhibitor drugs, or combining them with drugs of other types (immunotherapy, targeted therapy, or chemotherapy) is the future of treatment for many kinds of cancer. Literally hundreds of clinical trials are actively exploring these combinations, and melanoma is the cancer for which trials of this type abound. Last month, the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago featured just a few presentations in this area, apparently because it is too early to report results from the many ongoing trials with drug combinations. Continue reading…
“Patients with melanoma continued to experience tumor response to nivolumab monotherapy when treated beyond progression, according to a pooled analysis of data from the CheckMate 066 and CheckMate 067 studies.
” ‘The results of this analysis suggest that continued treatment with nivolumab [Opdivo, Bristol-Myers Squibb] may be an option to achieve further apparent clinical benefit in some patients with advanced melanoma,’ Georgina V. Long, PhD, BSc, MBBS, FRACP, chair of melanoma medical oncology and translational research at Melanoma Institute Australia and Royal North Shore Hospital of The University of Sydney in Sydney, Australia, and colleagues wrote.”
“Findings from a phase III clinical trial for advanced lung cancer patients could help oncologists better predict which patients are likely to receive the most benefit from immunotherapy as a first-line treatment based on the unique molecular characteristics of their tumor, according to a new study reported by a global team led by David Carbone, MD, PhD, of The Ohio State University Comprehensive Cancer – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).
“In this study, researchers compared the effectiveness of the immunotherapy drug nivolumab (pronounced ‘nye VOL ue mab,’ marketed at Opdivo), with standard-of-care chemotherapy in 541 patients with previously untreated or recurrent non-small cell lung cancer (NSCLC) that expressed PDL-1 antibodies.”
“Combining the IDO inhibitor epacadostat with nivolumab (Opdivo) demonstrated promising signs of activity for patients with squamous cell carcinoma of the head and neck (SCCHC) and those with melanoma, according to findings from the phase I/II ECHO-204 study presented at the 2017 ASCO Annual Meeting.
“The combination demonstrated an objective response rate (ORR) of 63% and a complete response (CR) rate of 5% for patients with treatment-naive melanoma, in the multi-arm, open-label trial. In those with SCCHC, the ORR was 23% and the CR rate was 3%. The combination was not effective in unselected patients with ovarian cancer and colorectal cancer (CRC).”
“Immunotherapy may represent an effective new treatment approach for relapsed mesothelioma patients, according to a new study.
“Anti–programmed death-1 (PD-1) immunotherapy may have activity as second- or third-line therapy in malignant pleural mesothelioma (MPM), an aggressive, rare cancer associated with asbestos exposure that has no curative treatment. All MPM patients relapse despite initial chemotherapy, and median overall survival (OS) is 9 months at most, said lead author Arnaud Scherpereel, MD, PhD, head of the pulmonary and thoracic oncology department at the University Hospital (CHU) of Lille in Lille, France, at a press briefing at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract LBA8507).”
“Nivolumab plus ipilimumab demonstrated an intracranial response (ICR) rate of 42% in asymptomatic patients with melanoma brain metastases who had not received prior local therapy to the brain.
“In the phase II Anti-PD1 Brain Collaboration (ABC) trial, the 6-month intracranial PFS rate was 46% with the anti–PD-1/CTLA-4 combination.
” ‘The combination of nivolumab and ipilimumab has high activity in melanoma brain metastases and may be considered for upfront therapy in such patients,’ said lead author Georgina V. Long, BSc, PhD, MBBS, clinical researcher at the Melanoma Institute Australia and Westmead Hospital in Sydney.”