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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Oncolytics Biotech® Inc. Reports Additional Data from Randomized Phase II Study of REOLYSIN® in Non-Small Cell Lung Cancer

Excerpt:

“Oncolytics Biotech Inc. …today announced additional data from IND 211, a randomized, Phase II clinical study of REOLYSIN® in patients with non-small cell lung cancer (“NSCLC”). The study enrolled patients with both non-squamous (adenocarcinoma) and squamous cell histology. Those with adenocarcinoma (n=75) were treated with REOLYSIN® in combination with pemetrexed in the test arm versus pemetrexed alone in the control arm. Those with squamous cell histology (n=76) were treated with REOLYSIN® in combination with docetaxel in the test arm versus docetaxel alone in the control arm. The study’s primary objective was progression free survival (“PFS”). Its secondary objectives included overall survival (“OS”), safety, and measurement of biomarkers that may be predictive of response.”

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Addition of Bevacizumab Shows No Survival Advantage Over Cisplatin Pemetrexed Alone in Non-Squamous NSCLC

Excerpt:

“Preliminary data from the SAKK19/09 trial shows no overall survival difference between two cohorts of patients with non-squamous non-small cell lung cancer (NSCLC) receiving similar cisplatin pemetrexed-based regimens.

“The SAKK19/09 trial examined a total of 77 patients with EGFR wild type non-squamous NSCLC. Both cohorts received cisplatin pemetrexed in the frontline, while one cohort had the addition of bevacizumab. In an interview with Targeted Oncology, Oliver Gautschi, MD, Assistant Professor, University of Bern, President, SAKK Lung Cancer Group, discusses the lack of differences in overall survival, where the field is going as a whole, and why combination maintenance therapy is not better than a single agent.”

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Crizotinib Tops Chemo for ALK-Positive NSCLC With Brain Metastases

Excerpt:

“First-line crizotinib therapy offered better intracranial disease control rate (IC-DCR) than chemotherapy in patients with ALK-positive non–small-cell lung cancer (NSCLC) and stable treated brain metastases, according to results of a phase III study.

“Earlier results from the ongoing PROFILE 1014 trial showed that crizotinib offers better progression-free survival (PFS) and response rates compared with pemetrexed-platinum chemotherapy. ‘Although the development of targeted therapies has improved outcomes for selected patient populations with oncogenic driver mutations, brain metastases are frequent and result in significant morbidity and mortality in patients with lung cancer,’ wrote study authors led by Benjamin J. Solomon, MBBS, PhD, of the Peter MacCallum Cancer Centre in East Melbourne, Australia.”

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Adding Atezolizumab to Chemotherapy Shows Promise in NSCLC

“The anti–PD-L1 agent atezolizumab (MPDL3280A) was recently investigated for safety and efficacy in combination with platinum-based doublet chemotherapy in treatment-naïve patients with advanced non–small cell lung cancer (NSCLC). Results from the phase Ib study were presented at the 2015 ASCO Annual Meeting.

“The multiple-arm study looked at MPDL3280A with a different chemotherapy backbone in each arm: carboplatin plus paclitaxel (Arm C; n = 8) carboplatin plus pemetrexed (Arm D; n = 14) or carboplatin plus nab-paclitaxel (Arm E; n = 15).

“Across all arms, the overall response rate (ORR) was 67% (48%-82%), with 60% ORR (19%-92%) in Arm C (3 partial responses [PRs]), 75% (45%-93%) in Arm D (9 PRs), and 62% (33%-83%) in Arm E (6 PRs, 2 complete responses).

“Regarding the safety profile, the researchers concluded that the combination regimens were well tolerated. The most frequent all-grade adverse events included those commonly associated with chemotherapy, such as nausea (Arms C and D, 50%; Arm E, 73%), fatigue (Arm C, 38%; Arm D, 36%; Arm E, 73%) and constipation (Arm C, 25%; Arm D, 71%; Arm E, 27%).

“OncLive spoke with Stephen Liu, MD, lead author on the study and assistant professor, Division of Hematology and Oncology, Georgetown University, to better understand the results and purpose of the uniquely designed trial, and how oncologists may need to rethink trial design when investigating similar novel agents.”


TS Expression Could Guide Treatment in Nonsquamous NSCLC

“The combination of pemetrexed and cisplatin was superior to gemcitabine and cisplatin only in those non-squamous non–small-cell lung cancer (NSCLC) patients who were negative for the enzyme thymidylate synthase (TS), suggesting it could be used as a predictive marker to guide treatment.

“Previous research has shown that pemetrexed/cisplatin offers superior survival in nonsquamous NSCLC, while gemcitabine/cisplatin was better in squamous NSCLC. “A plausible mechanism for the histotype-dependent efficacy of pemetrexed-based chemotherapy can be explained by the presence of different levels of TS according to histologic types, with adenocarcinoma of lung cancer exhibiting a lower TS protein expression level than squamous cell carcinoma or neuroendocrine carcinoma,” wrote study authors led by Myung-Ju Ahn, MD, PhD, of Sungkyunkwan University School of Medicine in Seoul.

“TS is involved in de novo DNA synthesis, and inhibiting the enzyme leads to arrested cell proliferation; pemetrexed’s antitumor effects arise from inhibition of TS. The new study’s results were published online ahead of print in the Journal of Clinical Oncology.”


OncoGenex and Sarah Cannon Announce Completion of Patient Enrollment in the Spruce™ Clinical Trial Evaluating Apatorsen in Combination with Carboplatin and Pemetrexed in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

“OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) and Sarah Cannon announced today that patient enrollment has been completed in the Spruce™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC). Spruce is sponsored and led by Sarah Cannon Research Institute (SCRI), the research arm of Sarah Cannon, Hospital Corporation of America’s (HCA) global cancer enterprise, and is being conducted at 16 sites across the United States.

“In the Spruce trial, approximately 155 patients were randomized to receive either apatorsen or placebo in combination with carboplatin and pemetrexed therapy. The primary objective of the trial is progression-free survival (PFS), with additional analyses to evaluate overall survival, tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.

” ‘Despite advances in targeted therapies to treat lung cancer, the majority of patients lack specific biomarkers and chemotherapy remains a mainstay of treatment for these patients,’ stated David Spigel MD, Director of the Lung Cancer Research Program at Sarah Cannon Research Institute and trial study chair. ‘The Spruce trial will enable us to better understand the role of apatorsen in treating NSCLC and its potential to delay or prevent treatment resistance and improve survival outcomes for these patients who urgently need more effective treatment options.’ “


New Drug to be Tested in Certain Patients with Advanced Non-Small Cell Lung Cancer

“Merrimack Pharmaceuticals, Inc. MACK, +1.95% today announced the initiation of a global, open-label, biomarker-selected, randomized Phase 2 clinical trial of MM-121, a fully human monoclonal antibody targeting ErbB3, in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer.

” ‘This marks the first MM-121 trial we’ve initiated where only patients with a high heregulin biomarker profile will be enrolled into the study. It builds on our learnings from the previous MM-121 Phase 2 clinical trials we completed across lung, ovarian and breast cancers where we saw a clear trend of patients in those studies with this biomarker profile benefitting from combining MM-121 with standard therapies,’ said Akos Czibere, MD, PhD, MM-121 Global Development Lead at Merrimack. ‘This study is a significant step toward preparing a registration trial of MM-121 in non-small cell lung cancer, and further supports Merrimack’s systems biology approach and its impact on drug discovery and development. We look forward to applying our clinical biomarker findings to future studies with MM-121 and ultimately improving outcomes in patients who no longer respond to standard-of-care therapies.’ “