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.
We begin this post with the immune checkpoint inhibitors, a type of immunotherapy that is explored in seemingly every type of cancer, including SCLC. Reports from two clinical trials of these drugs were recently made available at two meetings on lung cancer treatment. Continue reading…
“Bristol-Myers Squibb Company (NYSE:BMY) today announced new long-term data of Opdivo in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The two-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma. These data will be presented as a late-breaking presentation at the Society for Melanoma Research (SMR) 2015 International Congress in San Francisco, CA from November 18 to 21.”
“The FDA granted an accelerated approval to pembrolizumab (Keytruda) as a treatment for patients with pretreated advanced non–small cell lung cancer (NSCLC) across all histologies whose tumors express PD-L1. The PD-1 inhibitor was approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, and is indicated for patients who progressed on or after platinum-containing chemotherapy or EGFR-or ALK-targeted agents in patients harboring those mutations.
“The approval was based on data from the phase I KEYNOTE-001 trial, in which the overall response rate (ORR) with the drug was 41% among a subgroup of 61 patients with pretreated PD-L1–positive advanced NSCLC as determined by the 22C3 pharmDx diagnostic test. Response duration ranged from 2.1 to 9.1 months. A survival improvement has yet to be demonstrated in a clinical trial, and the accelerated approval is contingent upon the eventual outcomes of confirmatory studies.”
“Madison Vaccines Incorporated (MVI) today announced dosing has begun in a combination trial for MVI-816 (pTVG-HP), its lead prostate cancer vaccine, paired with pembrolizumab (Keytruda®), a PD-1 inhibitor, also called a checkpoint inhibitor. A PD-1 inhibitor works by exposing cancer cells to attack by the immune system by preventing the cancer cells from blocking an effective immune response. MVI-816, already in a Phase 2 clinical trial as monotherapy, has been shown to induce persistent T-cell responses in prostate cancer patients. The combination trial will test the hypothesis that both treatments work together synergistically. The first-of-its kind combination to reach this stage will be tested in men with metastatic, castrate-resistant prostate cancer, and will be conducted at the University of Wisconsin – Madison, Carbone Cancer Center under the direction of Douglas McNeel, MD, PhD, a leading prostate cancer researcher at the university.”
“A large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, the company said, positioning the medicine for far wider use than its already approved lung cancer and melanoma indications.
“The U.S. drugmaker on Friday said the study, called Checkmate-057, was stopped early after an independent data monitoring committee concluded that Opdivo provided a survival advantage over docetaxel, a standard chemotherapy, among patients with previously treated non-squamous non-small cell lung cancer (NSCLC).
“The so-called PD-1 inhibitor, which works by taking the brakes off the immune system, was approved by U.S. regulators last month to treat the less-common “squamous” form of NSCLC that had spread following treatment with chemotherapy.
“Opdivo is also approved for use against metastatic melanoma following treatment with Yervoy, another Bristol-Myers immuno-therapy.”
“Two studies indicate that using investigative immunotherapy drugs improves survival and response in patients with metastatic melanoma, researchers said here.
“In one study, the agent pembrolizumab (MK-3475) which targets the programmed death (PD-1) pathway produced a 1-year 69% survival rate, said Antoni Ribas, MD, PhD, professor of medicine at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles.
“In a second study reported in a press conference at the annual meeting of the American Society of Clinical Oncology, Mario Sznol, MD, professor of medicine at the Yale Cancer Center, demonstrated that a combination of the investigative PD-1 inhibitor nivolumab in combination with another targeted agent ipilimumab (Yervoy) produced a 1-year survival rate of 85% and 2-year survival rate of 79% for advanced melanoma patients.”
Editor’s note: Immunotherapy drugs boost a patient’s own immune system to fight cancer. Promising research into new immunotherapy drugs for melanoma was recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Two treatments that received special attention were MK-3475 (aka pembrolizumab) and a combination of the drugs ipilimumab (Yervoy) and nivolumab.