Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change?

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

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Expert Says Melanoma Clinical Trials Should Include More Patients With Brain Mets

Excerpt:

“Historically, patients with melanoma who develop brain metastases have been excluded from clinical trials, according to Harriet Kluger, MD.

“As of late, an increasing number of patients in this subgroup are being included now on studies, particularly those who have received prior treatment. Yet this is still not enough, says Kluger, as brain metastases is no longer the dismal prognosis that it once was.”

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FDA Approves First-of-a-Kind Test for Cancer-Gene Profiling

Excerpt:

“U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.

“The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

“The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now and will lead more insurers to cover it.”

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FDA Aims to Expand Early-Approval Program for Promising Drugs

Excerpt:

“The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.

“The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.

“Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”

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Glembatumumab Vedotin Induces Promising DCR in Uveal Melanoma

Excerpt:

“According to results from the phase II NCI9855 study, presented at the 2017 World Congress of Melanoma, glembatumumab vedotin (CDX-011) induced a 61% disease control rate (DCR) in patients with metastatic uveal melanoma, despite a low a low objective response rate (ORR) of 6%.

“There were no complete responses, 2 (6%) partial responses, and 17 patients (55%) with stable disease. Twelve patients (39%) experienced disease progression.”

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Study Questions Exclusion of Cancer Survivors from Trials

Excerpt:

“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.”

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NKTR-214/Nivolumab Combination Shows Promise in Early Study

Excerpt:

“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).”

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Neoadjuvant Nivolumab/Ipilimumab Combo Effective but Toxic for Melanoma

Excerpt:

“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.”

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Does Gut Flora Impact the Response to Cancer Immunotherapy?

Excerpt:

“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.”

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