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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Metastatic Melanoma: Not Quite Curable…But Getting There


By 2050, the number of deaths due to malignant melanoma in the U.S. could be three times lower than peak levels reached before 1960. Researchers presented the data behind this prediction at the 2017 European Cancer Congress in January.

It is unclear how much of this anticipated decline in deaths can be attributed to the availability of new, effective treatments. However, it is obvious that much-increased awareness of sunlight exposure as the single factor most responsible for the development of skin melanoma has contributed to lower incidence of the disease.

In any case, the armament of treatments available for metastatic melanoma is currently such that this diagnosis has transformed from being almost universally fatal (even just a few years ago) into a being largely treatable. Since 2011, the U.S. Food and Drug Administration (FDA) has approved eight new drugs for melanoma. Continue reading…


Expert Tackles Efficacy of PD-L1 Testing for NSCLC in 2017

Excerpt:

“In 2017, a lung cancer diagnosis must be accompanied by biomarker testing, whether it be for a genomic alteration, such as EGFR, ALK, or ROS1, or the immune marker PD-L1, according to Daniel B. Costa, MD, PhD, MMSc.

“Moreover, even with FDA-approved agents designed to target these abnormalities or expression levels, researchers are still hoping to uncover additional markers and match novel therapies to them.”

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Pembrolizumab Affords Long-Term Survival to One-Fourth of Selected Patients With NSCLC, Alternative Statistical Model Suggests

Excerpt:

“Statistical modeling of long-term survival from the KEYNOTE trials of the programmed cell death protein 1 (PD-1)–inhibitor pembrolizumab ­(Keytruda) estimates that one-quarter of appropriately selected patients with advanced non–small cell lung cancer (NSCLC) may attain long-term survival.

” ‘In the context of the pembrolizumab program, these are the furthest-out data that we have so far, and I think they represent a remarkable step forward,’ commented Matthew D. Hellmann, MD, of Memorial Sloan Kettering Cancer Center, New York, who presented the analysis at the 2017 ASCO-SITC (Society for Immunotherapy of Cancer) Clinical Immuno-Oncology Symposium.”

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Innovative Immunotherapy Combo Tests IDO Inhibitor in Melanoma Trial

Excerpt:

“Investigators are looking into a novel immunotherapy combination that pairs the first-in-class IDO1 inhibitor epacadostat (INCB024360) with the checkpoint blockade agent pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma.

“The phase III KEYNOTE-252/ECHO-301 trial, which is enrolling at more than 120 locations, will randomize 600 patients in a 1:1 ratio to either epacadostat combined with pembrolizumab or pembrolizumab plus placebo (NCT02752074).”

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