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FDA Grants Merck’s Anti-PD1 Antibody Priority Review

FDA Grants Merck’s Anti-PD1 Antibody Priority Review | Lung Cancer Dispatch | Scoop.it

"The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months."


Editor's note: MK-3475 is an immunotherapy drug that works by boosting a patient's own immune system to fight cancer. While this story is about melanoma, anti-PD1 drugs like MK-3475 have also shown promise for other cancers, including for lung cancer. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system. 

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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types

Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types | Lung Cancer Dispatch | Scoop.it

"Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of its investigational anti-PD-1 immunotherapy MK-3475 across multiple tumor types.  The agreements, of which financial terms were not disclosed, were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.

"As part of the new collaborations, Merck will begin several clinical trials. In these phase I/II studies, MK-3475 will be explored in combination with axitinib in renal cell carcinoma, talimogene laherparepvec (T-VEC) in previously untreated advanced melanoma, the immunotherapy INCB24360 in previously treated metastatic recurrent non-small cell lung cancer (NSCLC), and PF-2566 in multiple cancer types. Separate from these collaborations, Merck announced that the safety and efficacy of MK-3475 monotherapy would be evaluated in a phase I “signal finding” study in 20 PD-L1-positive solid tumor types not previously studied."

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OncLive  |  Feb 7, 2014

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Early Results For New Lung Cancer Immunotherapies Inspire Optimism

Three new immunotherapy drugs for non-small cell lung cancer (NSCLC) – nivolumab, lambrolizumab (MK-3475), and MPDL-3280A – have produced encouraging early results. All three interfere with PD-1 and PD-L1, molecules that interact to shield tumors from being attacked by the body's immune system. In phase I trials, more than 20% of participants experienced tumor shrinkage in response to each of the three drugs. For these patients, effects tended to be rapid and long-lasting. Most continue to respond favorably to treatment at this time, having been in the trials for up to 7 months (MPDL-3280A), an average of 9 months (lambrolizumab), or an average of 1.5 years and ranging up to 2.5 years (nivolumab). Overall toxicity was acceptable, though some cases of severe side effects were seen, including two deaths with nivolumab.

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Medscape | Oct 31, 2013

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Study Identifies Potential Predictor of Clinical Outcome in Patients With Lung Cancer Treated With the Investigational Immunotherapy MK-3475

Study Identifies Potential Predictor of Clinical Outcome in Patients With Lung Cancer Treated With the Investigational Immunotherapy MK-3475 | Lung Cancer Dispatch | Scoop.it

"Among patients with non-small cell lung cancer (NSCLC) treated with the investigational immune checkpoint inhibitor MK-3475, those whose tumors had high levels of the protein PD-L1 had significantly better outcomes, according to results of a phase I clinical trial presented here at the AACR Annual Meeting 2014, April 5-9.

"Preliminary data from the trial, which were reported earlier this year, showed that MK-3475 treatment was well tolerated and led to durable, objective responses in previously treated patients with NSCLC, particularly those with tumors found to have high levels of PD-L1 prior to treatment. 

"The latest results extend these data, showing that at six months after starting treatment, 41 percent of patients whose tumors had high levels of PD-L1 had no disease progression, compared with 17 percent of those whose tumors had low levels of PD-L1. Similarly, 72 percent of patients whose tumors had high levels of PD-L1 were alive at this time, compared with 53 percent of those whose tumors had low levels of PD-L1."


Editor's note: MK-3475 is an immunotherapy drug, which means it boosts a patient's own immune system to fight cancer. This study found that it was more effective in patients whose tumors had high levels of the protein PD-L1, as detected by molecular testing. To learn more about immunotherapy treatments for lung cancer, visit this blog post.

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AACR  |  Apr 6, 2014

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Biomarker May Predict Best Response to Lung Cancer Drug MK-3475

Biomarker May Predict Best Response to Lung Cancer Drug MK-3475 | Lung Cancer Dispatch | Scoop.it

An early clinical trial of the drug MK-3475 in non-small cell lung cancer (NSCLC) has yielded promising results. MK-3475 targets PD-1, a protein on the surface of immune cells. Another protein, PD-L1, is present on many tumor cells and can bind to PD-1, which deactivates immune cells. MK-3475 blocks PD-1, allowing the immune cells to keep attacking cancer cells. Patients with advanced NSCLC who had failed at least two other treatments were given MK-3475. Tumors shrank in 24% of the patients overall. However, tumor shrinkage occurred in 67% of patients with high levels of PD-L1 on their tumors, compared to only 9% of others. PD-L1 levels may therefore help predict which patients will likely respond to MK-3475.

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Medical Xpress  |  Jan 8, 2014

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New PD-1 Blocker May Shrink Lung Tumors

An experimental immunotherapy drug shrank tumors in a quarter of people with non-small cell lung cancer (NSCLC), report researchers from a small clinical trial. Called MK-3475, the drug blocks PD-1, a cell surface protein that disguises tumor cells from our immune systems. To see if these findings hold up in a larger, more rigorous trial, the researchers plan to start a phase II/III clinical trial soon.

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Bloomberg Businessweek │Oct 1, 2013

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