“The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) induced an intracranial response of 46% in melanoma patients with asymptomatic, untreated brain metastases. The intracranial response rate (ICR) with nivolumab monotherapy was 20%.
“Investigators observed a response in 16 of 35 evaluable patients treated with 1 mg/kg of nivolumab combined with 3 mg/kg of ipilimumab every 3 weeks for 4 doses, then 3 mg/kg of nivolumab every 2 weeks (cohort A). In contrast, only 5 of 25 evaluable patients randomly assigned to 3 mg/kg of intravenous nivolumab every 2 weeks (cohort B) showed a response.”
“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.
“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”
“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.
“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.
“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”
“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.
“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”
“Several trials either have been completed or are underway to evaluate new immunotherapeutic targets for patients with melanoma, according to a presenter at HemOnc Today New York.
” ‘When we think about where we’re going with immune therapy, it’s important to realize where we are and where have we been,’ Michael A. Postow, MD, assistant attending physician on the melanoma-sarcoma service at Memorial Sloan Kettering Cancer Center, said during his presentation. ‘What are the targets we have been using, and how do we modify what we know and explore totally new territory to try to improve outcomes?’ ”
“In the international phase III BRIM8 trial reported in The Lancet Oncology, Maio et al found inconclusive evidence of benefit of adjuvant vemurafenib treatment in patients with BRAF V600–mutant melanoma.”
“Vemurafenib offered numerical improvement in disease-free survival in a study of patients with completely resected stage IIC to IIIC BRAF V600 mutation–positive melanoma, but the results did not reach statistical significance. The benefit was bigger in those with stage IIC to IIIB disease, but this should be considered exploratory at this point.
” ‘Despite full resection, patients with stage IIC to III melanoma remain at high risk for disease recurrence and death,’ wrote study authors led by Michele Maio, MD, of University Hospital of Siena in Italy. ‘This situation warrants the use of adjuvant approaches to improve clinical outcomes.’ ”
“The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.”
“Circulating tumor DNA (ctDNA) can help differentiate what is known as pseudoprogression from true progression of disease in patients with melanoma who are treated with programmed death 1 (PD-1) inhibitors, according to a new study. It also showed that ctDNA could be used as a powerful biomarker to predict long-term outcomes.
” ‘Pseudoprogression, a response that occurs after the initial development of new lesions or an increase in the size of target lesions, occurs in up to 10% of patients treated with PD-1 antibodies,’ wrote study authors led by Jenny H. Lee, MBBS, of Macquarie University in Sydney, Australia. ‘Confirmation of pseudoprogression requires subsequent imaging, imposing an ongoing challenge.’ ”