On august 20, 2018, fda granted pembrolizumab keytruda regular approval for the initial, or firstline, treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors do not have mutations in the egfr or alk genes. Pembrolizumab plus chemotherapy in metastatic nonsmallcell lung cancer. Pembrolizumab for treating pdl1positive nonsmallcell lung. Introduction although treatment for nonsmallcell lung cancer has improved in recent years with the development of. Costeffectiveness of pembrolizumab versus chemotherapy as firstline treatment in pdl1positive advanced nonsmallcell lung cancer in the. Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression. Platinumbased chemotherapy has long been the firstline treatment of choice for metastatic nonsmallcell lung cancer nsclc patients who lack targetable gene mutations. Abstracts immunotherapy of cancer 336p pembrolizumab plus chemotherapy versus pembrolizumab monotherapy for pdl1 positive advanced nonsmall cell lung cancer in the real world j. Firstline pembrolizumab for metastatic nonsmallcell lung. Nejm jw oncol hematol jan 2017 and n engl j med 2016.
In nonsmallcell lung cancers with programmed deathligand 1 pdl1 expression on. Jci pembrolizumab plus allogeneic nk cells in advanced. Pembrolizumab versus chemotherapy for pdl1 positive nonsmallcell lung cancer nsclc date. Pulmonary sarcomatoid carcinoma is a rare nonsmall cell lung cancer nsclc subtype with a poor prognosis. Pembrolizumab in firstline treatment of metastatic non. Herbst rs, baas p, kim dw, felip e, perezgarcia jl, han jy, et al. Duration of chemotherapy for advanced nonsmall cell lung cancer. Pembrolizumab versus docetaxel for previously treated, pd l1positive, advanced non small cell lung cancer keynote010. Nov 25, 2016 on october 24, 2016, pembrolizumab keytruda was approved for use in patients with metastatic nonsmall cell lung cancer nsclc whose tumors have high programmed cell death ligand 1 pdl1 expression tumor proportion score. These data establish pembrolizumab as a new treatment option for this population and validate the use of pdl1 selection. Outcomes to firstline pembrolizumab in patients with non. Immunotherapy offers a novel approach for the treatment of these patients, with two antiprogrammed death 1 pd1 checkpoint inhibitors, nivolumab and pembrolizumab, recently approved by the fda based on large. Duration of chemotherapy for advanced nonsmallcell lung cancer.
Bc cancer protocol summary for treatment of advanced non. Pembrolizumab versus docetaxel for pre viously treated, pdl1 positive, advanced nonsmallcell lung cancer keynote 010. Pembrolizumab versus chemotherapy for pdl1 positive non. Pembrolizumab in firstline treatment of metastatic nonsmall. Jci pembrolizumab plus allogeneic nk cells in advanced non. Jun 28, 2019 platinumbased chemotherapy has long been the firstline treatment of choice for metastatic nonsmallcell lung cancer nsclc patients who lack targetable gene mutations. Aug 12, 2016 the purpose of this study is to assess the efficacy of pembrolizumab mk3475 versus docetaxel in participants with nonsmall cell lung cancer nsclc with programmed cell death ligand 1 pd l1 positive tumors who have experienced disease progression after platinumcontaining systemic therapy. The outcomes for patients with previously treated advanced stage nonsmall lung cancer nsclc are very poor, with a modest benefit from chemotherapy over best supportive care. Pembrolizumab as firstline treatment for nonsmallcell. The purpose of this study is to assess the efficacy of pembrolizumab mk3475 versus docetaxel in participants with nonsmall cell lung cancer nsclc with programmed cell death ligand 1 pd l1 positive.
Reck m 1, rodriguezabreu d 1, robinson ag 1, hui r 1, csoszi t 1, fulop a 1, gottfried m 1, peled n 1, tafreshi a 1, cuffe s 1, obrien m 1, rao s 1, hotta k 1, leiby ma 1, lubiniecki gm 1, shentu y 1, rangwala r 1, brahmer jr 1. Keytruda is a prescription medicine used to treat a kind of lung cancer called nonsmall cell lung cancer nsclc keytruda may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread advanced nsclc and is a type called nonsquamous and your tumor does not have an abnormal egfr or alk gene. Rodr\iguezabreu and andrew robinson and rina hui and tibor csoszi and andrea f\ul\op and maya gottfried and. Nivolumab and pembrolizumab for nonsmall cell lung cancer.
A micrograph showing a nonsquamous nonsmall cell lung cancer. Study of pembrolizumab versus docetaxel in participants. Jun 04, 2018 chicago firstline pembrolizumab conferred longer median os than chemotherapy among patients with nonsmall cell lung cancer and pdl1 expression, according to results of the phase 3 keynote. Pulmonary sarcomatoid carcinoma sc is a rare subtype of nonsmallcell lung cancer nsclc, accounting for approximately 0. Reck m, rodriguezabreu d, robinson ag, hui r, csoszi t, fulop a et al. In september 2017, this guidance was amended after a change to the commercial arrangements in august 2017. This change does not affect the cost effectiveness of pembrolizumab. Pembrolizumab for treating pdl1positive nonsmallcell. Pembrolizumab versus platinumbased chemotherapy for advanced nonsmallcell lung cancer with pdl1 tumor. N hui, t csoszi, a fulop, m gottfried, n peled, a tafreshi, s cuffe, m obrien, s rao, k hotta, m.
Background pembrolizumab is a humanized monoclonal antibody against programmed death 1 pd1 that has antitumor activity in advanced nonsmallcell lung cancer nsclc, with increased activity in. Herbst and others published pembrolizumab versus docetaxel for previously treated, pdl1 positive, advanced nonsmallcell lung cancer keynote010. In a prior study, survival was significantly longer with firstline pembrolizumab monotherapy than with platinumbased chemotherapy in patients with metastatic, nonegfr or non. Final appraisal determination pembrolizumab for treating pdl1 positive nonsmallcell lung cancer after chemotherapy issue date. Healthrelated qualityoflife results for pembrolizumab. Pembrolizumab versus chemotherapy for pdl1 positive nonsmallcell lung cancer by m reck, d rodriguezabreu, a. Evidencebased recommendations on pembrolizumab keytruda for treating pdl1 positive nonsmallcell lung cancer in adults who have had chemotherapy in september 2017, this. Food and drug administration fdaapproved test, with no epidermal growth factor receptor egfr or anaplastic lymphoma kinase alk. Pdl1 expression was reported as a percentage of tumor cells with positive membranous. Firstline pembrolizumab for metastatic nonsmallcell. Jan 11, 2017 evidencebased recommendations on pembrolizumab keytruda for treating pdl1 positive nonsmallcell lung cancer in adults who have had chemotherapy. Firstline pembrolizumab improves survival for pdl1.
Pembrolizumab versus docetaxel for previously treated, pdl1. Elderly patients and pdl1positive advanced nonsmall cell. N hui, t csoszi, a fulop, m gottfried, n peled, a tafreshi, s cuffe. Request pdf pembrolizumab versus chemotherapy for pdl1positive non smallcell lung cancer background pembrolizumab is a humanized. Favorable response to pembrolizumab after durvalumab failure. Current standard firstline treatment of advanced nonsmall cell lung cancer nsclc.
November 2016 2 the technology description of the technology. Firstline combination chemotherapy with pembrolizumab showed. Pembrolizumab for the treatment of nonsmall cell lung cancer. Pembrolizumab versus docetaxel for previously treated, pdl1 positive, advanced nonsmall cell lung cancer keynote 010. Outcomes to firstline pembrolizumab in patients with nonsmallcell. Apr 16, 2019 in a prior study, survival was significantly longer with firstline pembrolizumab monotherapy than with platinumbased chemotherapy in patients with metastatic, nonegfr or nonalk mutated nonsmallcell lung cancer nsclc and pdl1 tumor proportion score tps.
Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of. Pembrolizumab keytruda was approved for use in patients with metastatic nonsmall cell lung cancer nsclc whose tumors have high pdl1. Chicago firstline pembrolizumab conferred longer median os than chemotherapy among patients with nonsmall cell lung cancer and pdl1 expression, according to results of the. Pembrolizumab versus chemotherapy for pd l1positive non small cell lung cancer. Pdf pembrolizumab versus chemotherapy for previously. Pembrolizumab for nonsmall cell lung cancer improves. Fda expands approval of pembrolizumab for lung cancer. Lung cancer is the leading cause of cancer death in the united states. Pembrolizumab versus chemotherapy for pdl1 positive nonsmallcell lung cancer.
Results of a randomized phase iii study of patients with advanced nonsmall cell lung cancer nsclc showed that the immune checkpoint inhibitor pembrolizumab keytruda extended the length of time patients lived before their disease worsened progressionfree survival compared with chemotherapy. Pembrolizumab plus chemotherapy in metastatic nonsmall. Favorable response to pembrolizumab after durvalumab. Keytruda pembrolizumab for advanced nonsmall cell lung. The arrival of checkpoint blockade has led to a vast shift in the treatment landscape of nsclc. Pembrolizumab versus docetaxel for previously treated, pdl1 positive, advanced nonsmallcell lung cancer keynote010. I or pembrolizumab pem is associated with survival improvement as chemotherapy. Six versus fewer planned cycles of firstline platinumbased chemotherapy for nonsmall cell lung cancer. Pembrolizumab versus chemotherapy for pdl1positive nonsmallcell lung cancer. Costeffectiveness of pembrolizumab versus chemotherapy as first. Pembrolizumab had better efficacy than platinumbased chemotherapy as firstline therapy for patients with advanced nonsmallcell lung cancer nsclc with programmed cell deathligand 1 pdl1. Cost effectiveness of pembrolizumab vs chemotherapy as firstline. Whether higher pdl1 levels within the expression range of 50%100% predict for even greater benefit to pembrolizumab is currently unknown. Elderly patients and pdl1positive advanced nonsmall.
In the phase iii pacific study, durvalumab significantly improved progressionfree survival and overall survival versus placebo, in patients with stage iii nsclc who do not have disease progression after concurrent chemoradiotherapy. Pembrolizumab prolongs overall survival and has a favourable benefittorisk profile in patients with previously treated, pd l1positive, advanced non small cell lung cancer. In the united states, pembrolizumab is the emerging standard of care for the initial treatment of patients with advanced nonsmall cell lung cancer whose tumors express programmed. Keytruda is a prescription medicine used to treat a kind of lung cancer called nonsmall cell lung cancer nsclc keytruda may be used with the chemotherapy. Firstline pembrolizumab improves survival for pdl1positive. Pembrolizumab versus chemotherapy for pdl1positive non. Pembrolizumab versus chemotherapy for pdl1positive nonsmallcell lung cancer article in new england journal of medicine 37519 october 2016 with 466 reads how we measure reads. Results of a randomized phase iii study of patients with advanced non small cell lung cancer nsclc showed that the immune checkpoint inhibitor pembrolizumab keytruda extended the length of time patients lived before their disease worsened progressionfree survival compared with chemotherapy. Pembrolizumab versus docetaxel for previously treated, pd. Pembrolizumab had better efficacy than platinumbased chemotherapy as firstline therapy for patients with advanced nonsmall cell lung cancer nsclc with programmed cell deathligand 1 pd l1 positivity tumour proportion score of 50% or more and no sensitising egfr mutations or alk rearrangements enrolled in the keynote024 study. Food and drug administration fda approved pembrolizumab keytruda.
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