“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.
“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.
“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”
“The combination of the CD122-biased cytokine NKTR-214 and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72% for patients with advanced cancers, according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.
“The dose escalation trial enrolled patients in the first- or second-line setting with advanced non–small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma. The objective response rates (ORR) by RECIST criteria ranged from 46% to 75% across tumor types. Additionally, the combination was tolerable, with no discontinuations attributed to adverse events (AEs).”
“Neoadjuvant treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated almost a tripling in objective response rate (ORR) compared with the PD-1 inhibitor alone but at the cost of significant added grade 3 adverse events (AEs) for patients with high-risk resectable melanoma, according to a small study presented at the 2017 SITC Annual Meeting.
“In the combination arm (n = 11), the ORR was 73% and 50% of patients achieved a pathological complete response (pCR). With nivolumab alone (n = 12), the ORR was 25% and the pCR rate was 25%. Unfortunately, these gains in response were accompanied by 73% of patients in the combination arm having a grade 3 AE compared with just 8% in the single-agent arm. This high level of toxicity led the researchers to close the study early, according to Sangeetha M. Reddy, MD, MSci. Reddy worked on this trial with co-investigators Rodabe Amaria, MD, and Jennifer Wargo, MD.”
“Gut microbes can help or hinder cancer patients’ response to immunotherapy, two new studies suggested.
“In 112 melanoma patients undergoing anti-PD-1 immunotherapy, those with a high diversity of gut microbes had not yet reached median progression-free survival (PFS) after nearly 2 years, because less than half of them had progressed, while median PFS in the low-diversity group was 188 days (hazard ratio 3.57, 95% CI 1.02-12.52, P<0.05), said Jennifer Wargo, MD, of the MD Anderson Cancer Center in Houston, and colleagues.”
“The combination of an oncolytic virus plus a checkpoint inhibitor improved survival among patients with advanced melanoma compared with monotherapy, according to data from a phase 2 study published in Journal of Clinical Oncology.
“Novel monotherapies, such as ipilimumab (Yervoy, Bristol-Myers Squibb) — a CTLA-4 antibody — have ‘transformed patient care in advanced melanoma,’ the researchers wrote.”
“Glembatumumab vedotin (CDX-011) induced a disease control rate (DCR) of 61% in patients with metastatic uveal melanoma, despite a low a low objective response rate (ORR) of 6%, according to results from the the phase II NCI9855 study.
“There were no complete responses, 2 (6%) partial responses, and 17 patients (55%) with stable disease. Twelve patients (39%) experienced disease progression.”
“Immunopulse IL-12 monotherapy and in combination with pembrolizumab was associated with encouraging response rates and safety data in patients with melanoma who may not respond to anti-PD-1 therapy, according to a press release.
“The findings were presented at the 9th World Congress of Melanoma — A Joint Meeting with the Society for Melanoma Research. The data include a phase 2 Immunopulse IL-12 (OncoSec) monotherapy study with 51 patients and a phase 2 study of the immunotherapy in combination with pembrolizumab, which included 22 patients.”
“Immunotherapy has led a transformation for melanoma care but combinations of anti–PD-1 and CTLA-4 agents are toxic and biomarkers are not available to help personalized treatment, calling for further research into less toxic and more effective options, according to a presentation by Caroline Robert, MD, PhD, at the 2017 World Congress of Melanoma.
“At this point, the only approved immunotherapy combination remains the PD-1 inhibitor nivolumab (Opdivo) and the CTLA-4 inhibitor ipilimumab (Yervoy). However, research into combination approaches is now focusing on triplets of anti–PD-1 therapies and new checkpoints, such as IDO. Additionally, ongoing research continues to search of a biomarker of response for immunotherapy in melanoma.”
“Adding the immune stimulator ImmunoPulse IL-12 to pembrolizumab (Keytruda) produced promising activity among patients with melanoma identified as unlikely responders to anti–PD-1 therapies.
“Data from the phase II OMS-I102 trial presented at the 2017 World Congress of Melanoma showed that the combination induced an overall response rate (ORR) of 50% (n = 11) among 22 patients with baseline biomarker data suggesting they would not respond to anti–PD-1 therapy.”