I Thought Melanoma Would Kill Me. Here's Why It Didn't.

Excerpt:

“Several months ago, my wife, Françoise, and I attended something novel for melanoma patients: a survivors’ dinner. People said they wanted to make it an annual gathering. Planning anything that far in advance had been pointless for me. Two years ago, I was about to accept hospice care.

“When I was diagnosed in 1996, very early surgery was the only reliably successful treatment. A more advanced case was essentially a death sentence. Over the past five years, a series of revolutionary drugs have given me and many other people a surprisingly hopeful prospect. Nevertheless, the drugs’ development process has often been excruciating for participants in clinical trials, and the drugs’ remarkably high costs limit their value.”

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Study Finds First Evidence That PD-1 Antibody Could Help Men with Metastatic Prostate Cancer

Excerpt:

“Restoring tumor-specific immunity is a treatment strategy that works well in melanoma and lung cancer patients. Now a new study out of the OHSU Knight Cancer Institute is reviving hope that the approach also may help men with life-threatening prostate cancer.

“It is a surprising turnaround because prior results in men with aggressive, advanced-stage prostate cancer showed no evidence of anti-tumor activity with immune therapies that work by blocking PD-1 signals.

“In the study published today in the journal Oncotarget, 10 men with metastatic prostate cancer resistant to androgen deprivation therapy and the androgen receptor antagonist enzalutamide were treated with pembrolizumab, a monoclonal antibody that binds to the PD-1 receptor.”

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New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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First-in-Human CRISPR Immunotherapy Would Target PD-1

Excerpt:

“At a time when PD-1 inhibitors are dominating the immunotherapy field, a team of researchers is seeking to use groundbreaking CRISPR gene editing technology for the first time in human beings to create an engineered T-cell agent that would knock out the gene that controls the immune checkpoint’s activity.

“Plans for the complex therapy call for taking NY-ESO-1, a peptide-based form of adoptive immunotherapy already in clinical trials, and disrupting the activity of the PDCD1 gene that encodes PD-1 as well as the endogenous TRAC and TRBC genes, which control T-cell receptor (TCR) alpha and beta, respectively.

“The goal would be to enhance the immune response with NY-ESO-1 by eliminating genomic drivers that hamper T-cell proliferation and function, University of Pennsylvania (UPenn) researchers said in describing the proposed study before a National Institutes of Health (NIH) panel on June 21.”

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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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Pfizer Presents Data from Phase 1b Trial Investigating Utomilumab (a 4-1BB agonist) in Combination with a Checkpoint Inhibitor

Excerpt:

“Pfizer Inc. PFE -0.26% today announced results from a Phase 1b trial of Pfizer’s investigational immunotherapy agent utomilumab (the proposed non-proprietary name for PF-05082566), a 4-1BB (also called CD137) agonist, in combination with pembrolizumab, a PD-1 inhibitor, in patients with advanced solid tumors. This is the first reported study of a 4-1BB agonist combined with a checkpoint inhibitor. Encouraging safety data from the study were shared today as an oral presentation at the 52 [nd] Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“ ‘While these are early data, the combination of utomilumab with pembrolizumab demonstrates an encouraging safety profile and an early indication of potential anti-tumor activity across solid tumors,’ said Anthony W. Tolcher, M.D., director of clinical research at South Texas Accelerated Research Therapeutics (START) San Antonio. ‘We believe these results warrant further investigation to confirm whether combining utomilumab with a checkpoint inhibitor may amplify anti-tumor responses.’ ”

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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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