Merck’s KEYTRUDA® (Pembrolizumab) Plus Pemetrexed (ALIMTA®) and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as First-Line Treatment for Advanced Nonsquamous NSCLC in Phase 3 KEYNOTE-189 Study

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the KEYTRUDA-pemetrexed-platinum chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). In pre-specified exploratory analyses, an OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, including: patients whose tumors were negative for PD-L1 (HR=0.59 [95% CI, 0.38-0.92]); patients whose tumors had PD-L1 tumor proportion scores (TPS) of 1-49 percent (HR=0.55 [95% CI, 0.34-0.90]); and patients who had a TPS of greater than or equal to 50 percent (HR=0.42 [95% CI, 0.26-0.68]). The addition of KEYTRUDA to pemetrexed plus platinum chemotherapy also achieved a significant improvement in progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half for patients in the KEYTRUDA combination arm, compared with chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.00001). A PFS improvement in the KEYTRUDA combination group was observed in patients whose tumors were negative for PD-L1 (HR=0.75 [95% CI, 0.53-1.05]); patients with a TPS of 1-49 percent (HR=0.55 [95% CI, 0.37-0.81]); and patients with a TPS greater than or equal to 50 percent (HR=0.36 [95% CI, 0.25-0.52]). These results are being presented today in a plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #CT075), with simultaneous publication in The New England Journal of Medicine.”

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Ramalingam Highlights Immunotherapy Advances in NSCLC

Excerpt:

“Recently reported updates from the KEYNOTE-189 and IMpower150 trials demonstrated the powerful impact of adding immunotherapy to treatment regimens for patients with non–small cell lung cancer (NSCLC).

“In the phase III KEYNOTE-189 study, the combination of pembrolizumab (Keytruda) with chemotherapy in the frontline setting improved survival in patients with nonsquamous NSCLC. In this trial, which is the confirmatory trial for the FDA approval of pembrolizumab plus carboplatin/pemetrexed, patients received frontline pembrolizumab or placebo combined with pemetrexed and either cisplatin or carboplatin. The study met the primary endpoints of improved overall survival (OS) and progression-free survival (PFS), though full data have yet to be presented.”

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First-Line Keytruda Plus Chemotherapy Improves OS, PFS in Non-Small Cell Lung Cancer

Excerpt:

“The addition of pembrolizumab to pemetrexed and cisplatin or carboplatin improved OS and PFS as first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer, according to a manufacturer-issued press release.

“Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is indicated for the treatment of patients with unresectable or metastatic melanoma, in addition to the treatment of other cancer types.”

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Expert Highlights Immunotherapy Progress in Squamous Cell Lung Cancer

Excerpt:

“Combination regimens—particularly with checkpoint inhibitors and chemotherapy—are showing promise for the treatment of patients with squamous non–small cell lung cancer (NSCLC).

“Beyond the May 2017 FDA approval of pembrolizumab (Keytruda) plus carboplatin/pemetrexed for nonsquamous patients regardless of PD-L1 status, researchers are turning their focus to immunotherapy combinations in squamous patients in ongoing clinical trials. For example, the randomized, open-label, phase III IMpower131 study is evaluating the safety and efficacy of atezolizumab (Tecentriq) in combination with carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Abraxane) versus carboplatin/nab-paclitaxel in chemotherapy-naïve patients with stage IV squamous NSCLC (NCT02367794). The trial, which has a primary endpoint of progression-free survival, is expected to enroll 1021 patients.”

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ESMO 2017 Press Release: Combination Immunotherapy in Second/third Line Extends Mesothelioma Survival to 15 Months

Excerpt:

“Combination immunotherapy as second or third line treatment extends overall survival to at least 15 months in patients with pleural malignant mesothelioma, according to late-breaking results from the MAPS2 trial presented today at the ESMO 2017 Congress in Madrid.

“Malignant pleural mesothelioma (MPM) is a rare disease usually caused by occupational exposure to asbestos. First line therapy is pemetrexed and platinum chemotherapy, with or without bevacizumab. There is no approved second line treatment and drugs that have been tested in this setting had low efficacy, with a disease control rate under 30%. Phase II studies have shown promising activity of checkpoint inhibitors as second line treatment.”

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Nintedanib Chemo Combo Shows Benefit in Frontline Mesothelioma

Excerpt:

“Treatment with nintedanib plus pemetrexed and cisplatin improved progression-free survival (PFS) in the frontline setting by 3.7 months for chemotherapy-naive patients with malignant pleural mesothelioma (MPM), according to data reported at the 2017 ASCO Annual Meeting.

“In the phase II trial, known as LUME-Meso, the median PFS was 9.4 months with the nintedanib combination versus 5.7 months with pemetrexed and cisplatin alone (HR, 0.54; 95% CI, 0.33-0.87; P = .010). The median overall survival (OS) was 18.3 months with nintedanib versus 14.2 months with chemotherapy alone; however, this finding was not statistically significant (HR, 0.77; 95% CI, 0.46-1.29; P = .319).”

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Super ASK Patient: Phil Kauffman Finds Peace in a Pragmatic Approach to Lung Cancer Treatment

In November of 2014, Phil Kauffman went to his primary care doctor with what he thought was a broken rib. The doctor advised him to let it heal on its own—a standard approach for such maladies.

Phil, a retired engineering consultant who lives near San Diego, California, with his wife (their two daughters are grown), went home and waited for his rib to heal, but the pain stuck around for months.

In March of 2015 his doctor ordered an X-ray, but instead of a broken rib, it revealed suspicious spots in Phil’s lung. A CT scan found five lesions characteristic of lung cancer. His rib pain was caused by pleural effusion (liquid) in his right lung, which was extracted, and an examination of that liquid confirmed a diagnosis of stage IV non-small cell lung cancer (NSCLC).

Phil remembers that during the first week after his diagnosis he was paralyzed with fear. His brother in law, a physician, helped him snap out of it, assuring him that his treatment options guaranteed a survival period of at least a few years or maybe more, and that cancer research was progressing at such a fast rate that the prospect of extending his lifetime beyond a couple of years was good. Continue reading…


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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Adding Pemetrexed to Gefitinib Improves PFS in EGFR-Mutated NSCLC

Excerpt:

“The combination of pemetrexed and gefitinib offered improved progression-free survival (PFS) over gefitinib alone in East Asian patients with advanced nonsquamous non–small-cell lung cancer (NSCLC) and activating EGFR mutations, according to a new randomized, open-label study.

“EGFR tyrosine kinase inhibitors (TKIs) including gefitinib have been shown to improve outcomes in patients with EGFR-mutated NSCLC. ‘Given their different mechanisms of action, combination treatment with EGFR-TKIs and chemotherapy may further improve outcomes,’ wrote study authors led by James Chih-Hsin Yang, MD, PhD, of National Taiwan University Hospital in Taipei. Previous trials of such combinations have not shown clinical benefit, however, though this could have been because of antagonism between the agents used or because wild-type EGFR patients were included.”

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