ASCO 2017: I-SPY 2 Trial: Combination of Pembrolizumab Plus Standard Neoadjuvant Therapy in High-Risk Breast Cancer

Excerpt:

“At the 2017 ASCO Annual Meeting, results were presented from the phase II I-SPY 2 trial investigating pembrolizumab (Keytruda) in combination with standard therapy (paclitaxel followed by doxorubicin and cyclophosphamide) as a neoadjuvant treatment for patients with locally advanced triple-negative breast cancer or hormone receptor–positive/HER2-negative breast cancer (Abstract 506).

“Findings showed that the addition of pembrolizumab increased the estimated pathologic complete response rate nearly threefold in patients with triple-negative breast cancer (60% vs 20%) and in patients with hormone receptor–positive/HER2-negative breast cancer (34% vs 13%) compared to standard therapy. Overall, based on Bayesian predictive probability of success in a confirmatory phase III trial, pembrolizumab has graduated from the I-SPY 2 TRIAL for all signatures in which it was tested (triple-negative breast cancer, all HER2-negative, and hormone receptor–positive/HER2-negative).”

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Incyte ‘IDO’ Combination Lung Cancer Results Improve Slightly at ASCO17

Excerpt:

“The Wall Street gang attending the American Society of Clinical Oncology (ASCO) annual meeting here will be crowding around a scientific poster this morning, craning their necks to see updated results from a small clinical trial combining Incyte’s (INCY) IDO inhibitor epacadostat with Merck’s (MRK) checkpoint inhibitor Keytruda in patients with non-small cell lung cancer.

“The headline number: The overall response rate remains 35%, although two lung cancer patients now have improved to complete responses, another 12 patients have a partial response. The data are updated as of Feb. 27.”

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Pembrolizumab/Entinostat Active in Melanoma Patients Refractory to Checkpoint Inhibitors

Excerpt:

“Combining the PD-1 inhibitor pembrolizumab (Keytruda) with the HDAC inhibitor entinostat demonstrated promising clinical activity and acceptable safety in patients with melanoma who were refractory to immune checkpoint inhibitors.

“In the ongoing phase II ENCORE 601 trial, the PD-1/HDAC combination induced a response in 4 of 13 patients (31%; 95% CI, 9-61). The responses comprised 3 confirmed responses and 1 unconfirmed response, according to the study findings, which were presented in a poster at the 2017 ASCO Annual Meeting. An additional 4 patients achieved stable disease.”

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Radiation Therapy Can Enhance Effectiveness of Immunotherapy in People With Advanced Lung Cancer, UCLA Study Finds

Excerpt:

“A new study by UCLA scientists has found that the breakthrough immunotherapy drug pembrolizumab can be more effective in improving survival in people with non-small cell lung cancer (NSCLC) if they have previously received radiation therapy, compared to those without a history of radiation treatment. The findings are important as the strategies of combining radiation therapy with anti-PD-1 antibodies such as pembrolizumb are currently being explored, and have the potential to increase the overall benefit of immunotherapy for people with NSCLC, the most common form of lung cancer.”

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In Bold Move, FDA Approves Cancer Drug For Any Advanced Tumor With Genetic Changes

Excerpt:

“For the first time, the FDA has approved a drug for use in cancer—of any type—that harbors certain molecular features. Merck’s Keytruda, an immune oncology drug, may be prescribed for any resistant, metastatic tumor with microsatellite instability (MSI) or other evidence for defective DNA mismatch repair.

“This is good news for patients. Previously, Keytruda (pembrolizumab) was approved by the FDA for use in some forms of lung cancer, melanoma, head and neck cancer, and Hodgkin’s lymphoma. Now, patients can try this medication if they have advanced cancer of any form with pathological MSI or DNA mismatch repair defects. Microsatellite instability most often appears in colon cancers, affecting around 15% of cases. Variants of DNA mismatch repair genes are implicated in heritable cancer dispositions such as Lynch syndrome.”

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#ASCO17: Incyte Gets a Boost from a Series of Positive Data Snapshots for Its Epacadostat/Keytruda Combo

Excerpt:

“Wednesday evening brought with it the data dump on abstracts for the upcoming annual ASCO confab in Chicago in early June, and the big preliminary winner — not a big surprise — was Incyte, with a slate of new data points underscoring the potential of its leading, late-stage IDO1 drug epacadostat in combination with Merck’s Keytruda.

“Incyte shares $INCY swelled 9.5% in after-market trading as investors got a glimpse of things to come, with a 30%-plus response rate for a full slate of combination studies that are now pushing into Phase III development.”

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FDA Approves Combining Merck’s Keytruda With Chemotherapy in Lung Cancer Patients

Excerpt:

“U.S. health regulators approved expanding the use of Merck & Co.’s cancer drug Keytruda to include adding it to chemotherapy to treat lung cancer, broadening the drug’s potential market though evidence for the combination’s benefit is mixed.

“Keytruda, introduced in 2014, is one of a new wave of cancer drugs designed to work by harnessing the body’s own immune system to fight tumors. The U.S. Food and Drug Administration on Wednesday approved combining it with two chemotherapy agents, pemetrexed and carboplatin, to treat patients with an advanced form of lung cancer. Eli Lilly & Co. markets pemetrexed under the brand Alimta, and carboplatin is available generically.”

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White Blood Cell Count Predicts Response to Lung Cancer Immunotherapy

Excerpt:

“White blood cell counts can predict whether or not lung cancer patients will benefit from immunotherapy, according to research presented at the European Lung Cancer Conference (ELCC).

” ‘Immune checkpoint inhibitors such as and pembrolizumab significantly improve overall survival in some – but not all – patients with non-small cell lung cancer (NSCLC),’ said lead author Dr Marcello Tiseo, Coordinator of DMT Thoracic Oncology, University Hospital of Parma, Italy. ‘Researchers are looking for a predictive biomarker to select patients that will benefit from this treatment to avoid unnecessary toxicity and a waste of resources in patients who will not respond.’ ”

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Immunotherapy Agents, Combinations to Compete for Frontline NSCLC

Excerpt:

“Immunotherapy agents, both as monotherapy and in combination, are emerging in the pipeline of non–small cell lung cancer (NSCLC) and could end up competing as frontline treatment for patients, explains Sukhmani Padda, MD.

“For example, the PD-1 inhibitor pembrolizumab (Keytruda) is the sole immunotherapy agent approved in the first-line setting for patients with NSCLC; however, many other immunotherapy agents and combination regimens are in development that are aimed at this line of therapy.”

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