Can Patients Discontinue Immunotherapy and Still Benefit?

Excerpt:

“At present in clinical practice, immunotherapy with anti-PD-1 agents is administered indefinitely until intolerable toxicities or progressive disease sets in. But there has been anecdotal evidence that patients who stop treatment may still derive benefit, and now there is evidence of this from a post hoc analysis of a randomized study.

“It comes from the CheckMate 069 trial that evaluated the combination of nivolumab (Opdivo, Bristol-Myers Squibb Company) and ipilimumab (Yervoy, Bristol-Myers Squibb Company) vs ipilimumab alone in patients with metastatic melanoma.

“New results from a post hoc analysis of this trial, presented at the recent American Society of Clinical Oncology (ASCO) 2016 Annual Meeting (abstract 9518), show that a subgroup of patients who discontinued combination immunotherapy because of treatment-related adverse events achieved an impressive overall response rate (ORR) of 66%.”

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Treating 'Out-of-the-Box' Melanoma Patients With Anti-PD-1s

Excerpt:

“Clinical trials that led to the approval of new therapies often have strict exclusion criterion, and so yield no data on how the drugs fare in patients with preexisting conditions. For that, data from the real-world setting are needed, and the latest to come in for the anti-PD-1 immunotherapies are data to show that they are safe and effective even in patients with preexisting autoimmune diseases.

“Researchers reporting a retrospective study at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting say that the new data are reassuring and that preexisting autoimmune diseases should not preclude treatment with immunotherapy with the PD-1 inhibitors pembrolizumab (Keytruda, Merck & CO) and nivolumab (Opdivo, Bristol-Myers Squibb).”

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Combining BRAF Inhibition, Anti-PD-1 No Help in BRAF-Mutant Melanoma

Excerpt:

“Patients with BRAF-mutant melanoma obtained no survival benefit from combined treatment of anti-BRAF therapy and an immune checkpoint inhibitor, a retrospective analysis showed.

“Median progression-free survival (PFS) was 6.0 to 6.5 months in BRAF-inhibitor naive patients who received a PD-1/PD-L1 inhibitor alone or with a BRAF inhibitor. Patients with prior exposure to a BRAF inhibitor had a median PFS of 8.0 months with anti–PD-1 therapy and 4.5 months with combined treatment. Median overall survival was 10.5 to 12 months with a PD-1/PD-L1 inhibitor alone or in combination with a BRAF inhibitor, regardless of prior BRAF inhibitor exposure status.

“ ‘BRAF inhibitor-refractory patients derived no additional benefit with anti-PD therapy in combination with BRAF inhibition,’ Wen-Jen Hwu, MD, of MD Anderson Cancer Center in Houston, and colleagues concluded in a poster presentation at the 2016 ASCO Annual Meeting in Chicago. ‘Clinical findings are similar with either anti-PD alone or in combination with BRAF inhibition in terms of objective response rate (ORR), disease control rate (DCR), and overall survival (OS).’ ”

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New Data Evaluating KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer Demonstrate Response Rates Ranging from 48 to 71 Percent

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from an initial proof-of-concept study of KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, combined with standard treatments, one with bevacizumab and others without, in non-small cell lung cancer (NSCLC) including chemotherapy in previously untreated patients with NSCLC; the study showed overall response rates (ORR) ranging from 48 to 71 percent, depending on the therapy used. These data, from the phase 1/2 KEYNOTE-021 trial, will be presented today at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Shirish Gadgeel of the Barbara Ann Karmanos Cancer Institute (Abstract #9016) from 8:00 – 11:30 a.m. CDT (Location: Hall A) and in a poster discussion from 3:00 – 4:15 p.m. CDT (Location: E354b).

“ ‘Combining KEYTRUDA and chemotherapy in the first-line lung cancer treatment setting is an important part of our effort to develop more treatment options for patients with non-small cell lung cancer,’ said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. ‘This study has helped us to identify chemotherapy options for combination with KEYTRUDA regardless of PD-L1 expression to take forward in phase 3 trials.’ ”

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Distinct Features Associated With Benefit for BRAF/MEK Inhibition

Excerpt:

“With the development of novel targeted and immunotherapeutic agents that are more efficacious than traditional chemotherapy, treatment paradigms in melanoma have undergone major changes. Current recommendations for first-line systemic therapy for patients with advanced or metastatic melanoma consider BRAF mutation status, tumor growth rate, and the presence or absence of cancer-related symptoms.

“Immunotherapies with agents that block CTLA-4 or PD-1/PD-L1 checkpoints have been associated with durable responses in a subset of patients, and are often considered for patients with low-volume, asymptomatic metastatic melanoma. Targeted therapies, on the other side, are preferred for patients with BRAF-mutant tumors who have symptomatic disease and benefit from the rapid response associated with these agents.”

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One Honest Researcher and More Talk of Cure for Melanoma

Excerpt:

“Which anti-PD-1 immunotherapy should you choose for the treatment of advanced melanoma: nivolumab (Opdivo, Bristol-Myers Squibb) or pembrolizumab (Keytruda, Merck)?

“In a refreshing display of academic impartiality, pembrolizumab investigator Caroline Robert, MD, PhD, from the Institut Gustave-Roussy in Paris, said it doesn’t much matter.

” ‘Honestly, I don’t see any difference,’ she said when asked which drug is superior in terms of efficacy and safety at a presscast held in advance of the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.

“Dr Robert’s candor was trumped by scientific rigor from presscast host and ASCO President Julie Vose, MD, MBA, who is from the University of Nebraska in Omaha.”

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Expert Examines Immunotherapy Potential in Small Cell Lung Cancer

Excerpt:

“Several ongoing clinical trials are examining the efficacy and safety of immunotherapy agents in patients with small cell lung cancer (SCLC), explains David P. Carbone, MD, PhD.

“Two early phase studies have already shown encouraging results. In the phase I/II CheckMate-032 trial, pretreated patients with SCLC received monotherapy with the PD-1 inhibitor nivolumab (Opdivo) or the combination of nivolumab plus the CTLA-4 inhibitor ipilimumab (Yervoy). Data showed that the median progression-free survival (PFS) was 3.35 months with the combination and 1.38 months with nivolumab alone. Median OS was 7.75 months with the combination and 3.55 months with single-agent therapy. The objective response rate (ORR) with the combination was 31.1%.

“In the phase Ib KEYNOTE-028 trial, the PD-1 inhibitor pembrolizumab (Keytruda) had an ORR of 29.2% (95% CI, 12.6-51.1) in patients with SCLC who had prior chemotherapy.”

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Clinical Trial Versus Standard Protocol: Why and How to Enroll in a Trial


My job at Cancer Commons is to help cancer patients better understand and make decisions about their treatment. Through our Ask Cancer Commons service, I also strive to inform patients about new drugs in trials that they can discuss with their oncologists. Sometimes, I explain the rationale behind a patient’s current or upcoming treatment, and sometimes I try to convince patients to actually get treated, rather than hope that a vegetarian diet and herbal supplements will cure their metastatic disease. Continue reading…


Pembrolizumab Promising in Metastatic Triple-Negative Breast Cancer

Excerpt:

“Results from a phase Ib trial suggest that the programmed death 1 (PD-1) inhibitor pembrolizumab has activity and an acceptable toxicity profile as single-agent therapy in heavily pretreated, advanced triple-negative breast cancer (TNBC).

“ ‘TNBC tumors are frequently of high histological grade, present at an advanced stage, are typically more aggressive and difficult to treat than hormone receptor–positive tumors, and are associated with a higher risk of early relapse,’ wrote study authors led by Rita Nanda, MD, of the University of Chicago. ‘Given the suboptimal outcomes with chemotherapy, new targeted therapies for TNBC are urgently needed.’ ”

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