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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Sacituzumab Govitecan Shows Promise for Metastatic NSCLC

Excerpt:

“Treatment with sacituzumab govitecan induced objective responses and appeared tolerable in patients with metastatic non–small cell lung cancer who had received first-line platinum-based therapy, according to the results from an expansion cohort of a phase 1/2 study presented at the ASCO Annual Meeting.

” ‘This therapy showed efficacy for squamous and non-squamous patients as well as for patients with prior PD-1/PD-L1 therapy,’ D. Ross Camidge, MD, PhD, professor in the division of medical oncology and Joyce Zeff chair in lung cancer research at University of Colorado Anschutz Medical Campus, said during a presentation.

Sacituzumab govitecan (IMMU-132, Immunomedics) is an antibody drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti–Trop-2 humanized monoclonal antibody.”

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CHMP Recommends EU Approval for Roche's Avastin in Combination With Tarceva for Patients With a Specific Type of Advanced Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.”

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EU Expands Nivolumab Approval for Lung and Kidney Cancer

Excerpt:

“The European Commission has approved new indications for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb), expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).

“The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and monotherapy in locally advanced or metastatic disease.

“Nivolumab is the only PD-1 inhibitor that has been approved for a broad range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and nivolumab is the only approved PD-1 inhibitor to demonstrate a better overall survival rate than docetaxel in previously treated metastatic NSCLC, the manufacturer pointed out in a press release.”

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Bristol-Myers Squibb’s Opdivo (nivolumab) Receives Expanded FDA Approval in Previously-Treated Metastatic Non-Small Cell Lung Cancer (NSCLC), Offering Improved Survival to More Patients

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivodemonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis. The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.”


Nivolumab Improves the Proportion of Lung Cancer Patients Alive After More than a Year

“Patients with a type of lung cancer called non-squamous non-small cell lung cancer (non-SQ NSCLC) have limited treatment options and a dismal prognosis once their disease has advanced and initial treatment with platinum-based chemotherapy has failed. Second-line treatment is usually with another chemotherapy drug, such as docetaxel or pemetrexed.

“Recent results have shown that the drug, nivolumab, improves survival for these and now updated results from the CheckMate 057 phase III clinical trial, to be reported at the 2015 European Cancer Congress today (Monday) with simultaneous publication of the study results in the New England Journal of Medicine, show that nivolumab continues to show an overall survival benefit compared to . Among patients randomised to receive nivolumab, significantly more were alive at 12 months compared to those treated with docetaxel – 51% versus 39% respectively – and a difference in survival remains at 18 months – 39% for nivolumab versus 23% for docetaxel.

“This improvement in survival was observed for all patients included in the trial, but nivolumab was more effective in patients whose tumours expressed a protein called programmed death ligand 1 (PD-L1), which plays a role in the immune system’s ability to recognise and attack tumours and has been correlated with response to immune checkpoint inhibitors such as nivolumab.”


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.”