Sentences with phrase «for pembrolizumab»

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For those taking pembrolizumab, there needs to be a certain threshold of PD - L1 expressed on the tumor for treatment, according to the FDA's labFor those taking pembrolizumab, there needs to be a certain threshold of PD - L1 expressed on the tumor for treatment, according to the FDA's labfor treatment, according to the FDA's label.

On May 23, the Food and Drug Administration approved pembrolizumab for cancer patients with mismatch repair mutations for whom other drugs have failed.

We are currently waiting for the results of several trials including EORTC 1325 which is investigating pembrolizumab, a PD - 1 checkpoint blocking antibody, compared to placebo in the adjuvant setting.»

Pembrolizumab and nivolumab, for example, the newest inhibitors to win FDA approval, target a checkpoint called PD - 1, through which tumors can induce a T cell to deactivate.

Since approving ipilimumab five years ago, the Food and Drug Administration has OK'd two similar drugs — pembrolizumab and nivolumab — for melanoma and certain lung cancers.

«The objective overall response rate for the single agent pembrolizumab was up to 35 percent, but why shouldn't more patients respond?»

«All endpoints of efficacy and tolerability favoured treatment with pembrolizumab, suggesting it should become one standard of care for first line treatment of patients with advanced NSCLC and high PD - L1 expression.

In Cohort A, pembrolizumab shrunk tumors by more than 30 percent in eight of 170 patients, or five percent, and stabilized the disease in 35, or 21 percent, of those previously treated for mTNBC.

The immunotherapy drug pembrolizumab — already FDA - approved for other forms of cancer - has been found to be effective in patients with metastatic triple negative breast cancer, according to an international clinical trial led by NYU Langone's Perlmutter Cancer Center.

Pembrolizumab is set to become a new option for first line treatment of patients with advanced lung cancer and high PD - L1 expression, according to the results of the phase III KEYNOTE - 024 trial presented at the ESMO 2016 Congress in Copenhagen and published in the New England Journal of Medicine.

«The reason KEYNOTE - 024 met its primary endpoint, in contrast with other studies, is probably because the trial only included patients who had PD - L1 expression of at least 50 % and were therefore optimal candidates for treatment with pembrolizumab,» he added.

UNC Lineberger researchers are planning to launch an investigator - initiated clinical trial year to assess whether the combination denosumab with the checkpoint inhibitor pembrolizumab is more effective than pembrolizumab alone for treating patients with advanced melanoma.

The goals of Cohort B, for which survival data are not yet complete, were, primarily, to prove pembrolizumab's safety and, secondarily, to explore its efficacy as a first - line treatment.

«Immunotherapy drug effective for metastatic triple negative breast cancer: Pembrolizumab shown to shrink tumors — regardless of whether patient had prior treatment.»

These results support the use of pembrolizumab as the new standard of care for advanced bladder cancer,» concluded Dr Necchi.

In addition to helping patients live longer, more patients treated with pembrolizumab responded to treatment and for a longer duration than those treated with chemotherapy; the objective response rate — the percentage of patients whose tumours shrank or disappeared — was almost twice as high with pembrolizumab: 21 % compared to 11 % on chemotherapy.

Clinical trials of a new immunotherapy, pembrolizumab, have shown that it prolongs life significantly for patients with bladder cancer and is active against a rare sub-type of melanoma, called mucosal melanoma.

The median duration of response for patients who responded to pembrolizumab has not been reached, while the median duration of response for patients who responded to chemotherapy was only 4.3 months.

We estimate that almost twice as many pembrolizumab responders will respond to the therapy for at least one year: 68 % versus 35 %.»

Reporting the results from three trials of pembrolizumab for patients with advanced melanoma, Dr Marcus Butler, a medical oncologist at the Princess Margaret Cancer Centre, Toronto, Canada, told ECCO2017 that 84 of the 1567 patients in the KEYNOTE - 001, 002 and 006 studies had advanced mucosal melanoma.

The KEYNOTE - 45 study randomised 542 patients from 29 countries between November 2014 and November 2015 to either pembrolizumab (200 mg, given intravenously once every three weeks for up to 24 months) or one of three chemotherapy options chosen by study investigators.

«Immunotherapy, pembrolizumab, is active against mucosal melanoma tumors: And prolongs survival for patients with bladder cancer.»

It represents a real advance in the second - line treatment of advanced bladder cancer because pembrolizumab is the first therapy to show a significant survival advantage over chemotherapy for these patients.

In 2017, the U.S. Food and Drug Administration (FDA) approved the cancer drug Keytruda (pembrolizumab) for a range of solid tumors that are either microsatellite instability - high (MSI - H) or mismatch repair deficient (dMMR).

Alley said there are already plans for trials that will test combination therapies, which will utilize pembrolizumab in conjunction with other treatments.

In fact, the Food and Drug Administration's approval of pembrolizumab in May 2017 for adult and pediatric patients with solid tumors and high microsatellite instability, was the first time it had approved a cancer treatment based on a genetic feature rather than the cancer's location of origin.

Pembrolizumab is the sixth immunotherapy (and fifth anti-PD-1 / PD - L1 checkpoint inhibitor) to be approved for bladder cancer patients.

Pembrolizumab is approved for the treatment of both squamous and non-squamous non-small cell lung cancer (NSCLC) that is no longer responding to standard - of - care chemotherapy.

Pembrolizumab is the third immunotherapy (and first checkpoint inhibitor) to be approved for patients with stomach and gastroesophageal cancer.

The FDA granted approval to pembrolizumab (Keytruda), a anti-PD-1 checkpoint inhibitor, for metastatic non-small cell lung cancer patients whose tumors express PD - L1.

A Randomized, Phase III Trial to Evaluate The Efficacy and Safety of MK - 3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor - Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (yPN +) After Neoadjuvant Chemotherapy

Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, Hodi FS, Schachter J, Pavlick AC, Lewis KD, Cranmer LD, Blank CU, O'Day SJ, Ascierto PA, Salama AK, Margolin KA, Loquai C, Eigentler TK, Gangadhar TC, Carlino MS, Agarwala SS, Moschos SJ, Sosman JA, Goldinger SM, Shapira - Frommer R, Gonzalez R, Kirkwood JM, Wolchok JD, Eggermont A, Li XN, Zhou W, Zernhelt AM, Lis J, Ebbinghaus S, Kang SP, Daud A. Pembrolizumab versus investigator - choice chemotherapy for ipilimumab - refractory melanoma (KEYNOTE - 002): a randomized, controlled, phase 2 trial.

On October 2, 2015, the FDA approved the immunotherapy drug pembrolizumab (Keytruda ®), made by Merck, as second - line treatment for patients with lung cancer, the leading cause of cancer - related death in the U.S. and the world.

The FDA granted approval to pembrolizumab (Keytruda, Merck), a checkpoint immunotherapy that targets the PD - 1 pathway, as a second - line treatment for advanced bladder cancer.

The FDA granted accelerated approval to pembrolizumab (Keytruda), an anti-PD-1 checkpoint inhibitor, for patients with recurrent or metastatc head and neck squamous cell carcinoma (HNSCC).

The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) as a second - line treatment for all metastatic solid tumor types classified as MSI - hi (high microsatellite instability) or dMMR (deficient DNA mismatch repair).

The FDA also approved another immunotherapy drug, Merck's pembrolizumab, known commercially as Keytruda, for patients with tumors harboring this defect regardless of cancer type.

The Food and Drug Administration has cleared four checkpoint inhibitors for adults: Yervoy, also known as ipilimumab; Keytruda, or pembrolizumab; Opdivo, or nivolumab, and Tecentriq, or atezolizumab.

Most recently, pembrolizumab (Keytruda ®), an anti-PD-1 checkpoint immunotherapy, was approved for patients with advanced, relapsed stomach cancer that expresses PD - L1.

With the recent presentation of the data from Keynote - 024, and the recent approval of pembrolizumab for high PD - L1 expressing tumors, the landscape of lung cancer oncology will change dramatically and for the better.

Zakharia, who presented the data at the 2017 American Association for Cancer Research (AACR) Annual Meeting in Washington, DC, reveals the overall response data from the trial, toxicity data, and compares the results to historical data of pembrolizumab monotherapy from KEYNOTE - 006, which included similar patients.

Because they stimulate the immune system rather than introducing an agent or process that can kill healthy cells along with the malignant ones, these therapies — which include commonly prescribed treatments such as trastuzumab (Herceptin), pembrolizumab (Keytruda) and nivolumab (Opdivo)-- have been noteworthy not only for their effectiveness but for their tolerability.

Rizvi called pembrolizumab a «promising new approach» for the treatment of non-small cell lung cancer.

Pembrolizumab (Keytruda) and nivolumab (Opdivo)-- two checkpoint inhibitors that target the PD - 1 pathway — received FDA approval in 2014 for melanoma that did not respond to prior treatment.

In one trial, patients treated with pembrolizumab had an overall response rate of 33 %, compared with 12 % for ipilimumab.

If approved by the FDA in October for the treatment of refractory melanoma, pembrolizumab would be the first PD - 1 checkpoint inhibitor approved in its class, beating out BMS's nivolumab in the race to the finish line — or starting line, really, since both drugs will likely have multiple future uses.

Ramuacirumab (CYRAMZA ®), an anti-VEGFR2 targeted antibody, is also appproved for esophageal cancer patients, while pembrolizumab (Keytruda ®), an anti-PD-1 checkpoint immunotherapy, is approved for patients with advanced cancers of the gastroesophageal junction that express PD - L1.

Merck's anti-PD-1 drug pembrolizumab (MK - 3475) is currently being investigated in a large a phase I trial for patients with metastatic melanoma and lung cancer.

The KEYNOTE - 183, KEYNOTE - 185, and KEYNOTE - 023 trials evaluating the programmed death 1 (PD - 1) inhibitor pembrolizumab in combination with pomalidomide or lenalidomide for patients with multiple myeloma were placed on hold due to the increase in deaths on the pembrolizumab arms of KEYNOTE - 183 and KEYNOTE - 185 trials.

In 2015 and 2016, the FDA expanded its approval of pembrolizumab and nivolumab as first - line treatments for unresectable or metastatic melanoma, regardless of mutational status.