Rizvi Recounts Recent Immunotherapy Advances in Lung Cancer

Excerpt:

“With frontline pembrolizumab (Keytruda) recently receiving a priority review, immune checkpoint therapy has moved 1 step closer to regulatory approval as a first-line treatment for non–small cell lung cancer (NSCLC).

“The review is based on data from from the phase III KEYNOTE-024 trial, in which frontline pembrolizumab improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with NSCLC and PD-L1 expression levels ≥50%.”

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Keytruda Receives FDA Breakthrough Therapy Designation, Priority Review for First-Line NSCLC

Excerpt:

“The FDA today granted breakthrough therapy designation and priority review to pembrolizumab for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1, according to the drug’s manufacturer.

“The phase 3 KEYNOTE-024 study — designed to compare pembrolizumab (Keytruda, Merck) monotherapy with standard chemotherapy — included 305 patients with advanced disease.

“All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.”

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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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Is Keytruda Better than Opdivo?

Excerpt:

“Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say.

“The yet-to-be-published studies involve drugs in a new class designed to enable the body’s immune system to fight cancer.

“A recent trial of Merck’s Keytruda (pembrolizumab) showed that it worked better than chemotherapy as an initial treatment for advanced non-small cell lung cancer (NSCLC) in patients with high levels of the PDL1 protein, believed to help identify those most likely to benefit from this type of immunotherapy.”

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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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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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Avelumab Promising in Unresectable Mesothelioma

Excerpt:

“The novel anti-PD-L1 agent avelumab showed some promising clinical activity and was generally well tolerated in a phase I trial of patients with unresectable, previously treated mesothelioma. Results of the trial were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago.

“ ‘Approximately 3,000 new cases of malignant mesothelioma are diagnosed each year in the United States,’ said Raffit Hassan, MD, of the National Cancer Institute in Bethesda, Maryland, who presented the study. The current standard treatment of pemetrexed and cisplatin yields a median overall survival of 12.1 months, and there is no US Food and Drug Administration (FDA)-approved therapy for patients progressing after first-line chemotherapy.

“Avelumab is a fully human anti-PD-L1 IgG1 antibody; it is under investigation in multiple malignancies. PD-L1 is expressed on the surface of mesothelioma cells, providing a rationale for avelumab’s use in this malignancy. In the new JAVELIN study, more than 1,600 patients have been treated with the drug across a variety of malignancies; in this analysis, 53 patients with unresectable pleural or peritoneal mesothelioma were included. All patients had progressed after a platinum/pemetrexed-containing regimen; they were unselected for PD-L1 expression.”

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Nivolumab/Ipilimumab Frontline Response Nears 60% in PD-L1+ NSCLC

Excerpt:

“Upfront treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated an objective response rate (ORR) of 57% in patients with PD-L1-positive advanced non–small cell lung cancer (NSCLC), according to updated pooled findings from the phase Ib CheckMate-012 study presented at the 2016 ASCO Annual Meeting.

“In the 3-arm study, patients received nivolumab alone or in combination with ipilimumab every 6 weeks (Q6W) or every 12 weeks (Q12W). Across the full population, which was not selected based on PD-L1 expression, single-agent nivolumab had an ORR of 23%. In the combination arms, the ORRs were 47% and 39%, in the Q12W and Q6W arms, respectively.”

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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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