“Patients with advanced unresectable melanoma can safely receive combination therapy with full doses of talimogene laherparepvec and pembrolizumab, according to study results presented at HemOnc TodayMelanoma and Cutaneous Malignancies.
“In previous studies, talimogene laherparepvec (Imlygic, Amgen) — a herpes simplex virus-1-based oncolytic immunotherapy — significantly improved durable response rate in patients with advanced melanoma. Also, pembrolizumab (Keytruda, Merck) — an anti–PD-1 antibody — showed superiority over ipilimumab (Yervoy, Bristol Meyers Squibb) in patients with stage III or IV melanoma.
“Both drugs appeared tolerable and demonstrated nonoverlapping adverse event profiles…”
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“Tumor infiltrating lymphocyte (TIL) technology represents an intriguing way of overcoming the immunosuppressive power of cancer, according to Jeffrey S. Weber, MD, PhD.
“Weber provided an overview of the technology and discussed its potential benefit to oncologists and oncology professionals in a lecture presented by Targeted Oncology on February 19, 2016.
“ ‘It’s yet another way of inducing remissions of long duration using an immunotherapeutic approach that’s different than ipilimumab and different than nivolumab or pembrolizumab,’ said Weber, the deputy director of the Laura and Isaac Perlmutter Cancer Center, co-director of the Melanoma Program, and head of Experimental Therapeutics at NYU Langone Medical Center. ‘It’s got its own toxicity, but you can fail this therapy and respond to ipilimumab or respond to nivolumab or pembrolizumab. You can fail nivolumab or pembrolizumab or ipilimumab and respond to this—they’re not cross-reactive.’ “
“Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.
“The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.
“Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.”
“Although nivolumab (Opdivo) and ipilimumab (Yervoy) together demonstrate superior survival in previously untreated patients with advanced melanoma, the combination comes with additional toxicity and an increased price tag, says Jason Luke, MD, assistant professor of Medicine at the University of Chicago Medicine.
“ ‘There have been several studies designed around trying to predict which patients are most likely to benefit from anti–PD-1 or immunotherapy combinations. I really think that is going to be an essential part of the future approach to treatment, says Luke. ‘Not all patients respond to these treatments. There are additional toxicities with the combinations, and there are also cost issues because of how catastrophically expensive these drugs are. We really need to know which patients are most likely to respond and which aren’t.’ “
Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…
“The FDA has expanded the approval for single-agent pembrolizumab (Keytruda) to include the frontline treatment of patients with advanced melanoma regardless of BRAF status, based on a substantial improvement in progression-free and overall survival compared with ipilimumab (Yervoy) in the phase III KEYNOTE-006 trial.
“In the study, which compared 2 pembrolizumab regimens with ipilimumab, the PD-1 inhibitor reduced the risk of disease progression by >40% and the risk of death by >30%.
“ ‘As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma,’ Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, the developer of the PD-1 inhibitor, said in a statement. ‘Today’s news is another exciting milestone for Keytruda and for patients with this disease.’ “
Any type of advanced lung cancer is bad news, but a diagnosis of small cell lung cancer (SCLC) is a particularly grim one to receive. About 30 years have passed since any new treatments for SCLC were developed, and patients’ responses to standard chemotherapy with etoposide and cisplatin are short-lived. Hopefully, this will change soon.
“A combination of pembrolizumab and low-dose ipilimumab appears to be active and to have a better safety profile than a combination of nivolumab and full-dose ipilimumab in advanced melanoma patients, according to a new study presented at the Society for Melanoma Research 2015 International Congress, held November 18–21 in San Francisco.
“Pembrolizumab is a potent, highly selective, humanized monoclonal antibody against programmed death-1 (PD-1) that has shown robust antitumor activity against several advanced malignancies. In phase I testing, combination therapy with the anti–PD-1 antibody nivolumab and full doses (3 mg/kg) of the anti–CTLA-4 therapy ipilimumab was seemingly associated with improved response rates, but also led to increased toxicities, said Georgina Long, BSc, PhD, MBBS, of the Melanoma Institute Australia in Sydney, Australia.”
“The checkpoint inhibitors pembrolizumab and nivolumab not only prolong survival in advanced melanoma patients but also maintain health-related quality of life (QoL), according to two presentations at the Society for Melanoma Research 2015 International Congress, held November 18–21 in San Francisco.
“In the international, randomized, open-label phase III KEYNOTE-006 study, the anti–programmed death-1 (PD-1) humanized monoclonal antibody pembrolizumab provided superior overall survival (OS), progression-free survival (PFS), and response, and with less high-grade toxicity compared with the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor ipilimumab in 834 patients with ipilimumab-naive advanced melanoma who received up to one prior therapy.”