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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Video: Dr. Ribas on Triplet Regimens in Melanoma

Excerpt:

“Antoni Ribas, MD, PhD, professor of Hematology and Oncology and director of the Tumor Immunology Program Area at UCLA Jonsson Comprehensive Cancer Center, discusses triplet therapies for patients with melanoma and the sequencing challenges associated with the approvals of additional agents in the field.

“Though current immunotherapy regimens are showing significant activity in patients, Ribas says the response rate is not 100%; therefore, there needs to be investigations of other ways to modulate the immune system. Patients who benefit from PD-1 monotherapy should not receive any more, as it will lessen treatment-related toxicities, he adds.”

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EU Expands Nivolumab Approval for Lung and Kidney Cancer

Excerpt:

“The European Commission has approved new indications for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb), expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).

“The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and monotherapy in locally advanced or metastatic disease.

“Nivolumab is the only PD-1 inhibitor that has been approved for a broad range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and nivolumab is the only approved PD-1 inhibitor to demonstrate a better overall survival rate than docetaxel in previously treated metastatic NSCLC, the manufacturer pointed out in a press release.”

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Advaxis Combination Trial with Merck Completes First Two Dose-Escalation Cohorts

Excerpt:

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck & Co., Inc. (MRK), today announced that they have completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in their KEYNOTE-046 clinical trial. The Phase 1/2 study is evaluating the combination of ADXS-PSA (ADXS31-142) and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

“The KEYNOTE-046 trial is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.”

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Pexidartinib Plus Pembrolizumab Combo Tested in Ovarian and Other Solid Tumors

Excerpt:

“An ongoing clinical trial has begun the process of evaluating whether the addition of a booster agent can take the anticancer activity of PD-1 directed immunotherapy to another level.

“Investigators in a multicenter trial are evaluating the impact of pexidartinib (PLX3397)—an inhibitor of colony stimulating factor 1 (CSF1)—on the activity of the PD-1 signaling inhibitor pembrolizumab (Keytruda) in various types of solid tumors.

“The two-part phase 1/2 trial will establish a recommended dose for pexidartinib to use in combination with standard pembrolizumab dosing and then evaluate the combination in 500 patients representing 12 types of cancer.”

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