Avelumab Promising in Unresectable Mesothelioma

Excerpt:

“The novel anti-PD-L1 agent avelumab showed some promising clinical activity and was generally well tolerated in a phase I trial of patients with unresectable, previously treated mesothelioma. Results of the trial were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago.

“ ‘Approximately 3,000 new cases of malignant mesothelioma are diagnosed each year in the United States,’ said Raffit Hassan, MD, of the National Cancer Institute in Bethesda, Maryland, who presented the study. The current standard treatment of pemetrexed and cisplatin yields a median overall survival of 12.1 months, and there is no US Food and Drug Administration (FDA)-approved therapy for patients progressing after first-line chemotherapy.

“Avelumab is a fully human anti-PD-L1 IgG1 antibody; it is under investigation in multiple malignancies. PD-L1 is expressed on the surface of mesothelioma cells, providing a rationale for avelumab’s use in this malignancy. In the new JAVELIN study, more than 1,600 patients have been treated with the drug across a variety of malignancies; in this analysis, 53 patients with unresectable pleural or peritoneal mesothelioma were included. All patients had progressed after a platinum/pemetrexed-containing regimen; they were unselected for PD-L1 expression.”

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ASCO 2016: New Antibody-Drug Conjugate Shows Early Promise in Small Cell Lung Cancer

Excerpt:

“Early findings from a first-in-human clinical trial showed that the antibody-drug conjugate rovalpituzumab tesirine (Rova-T) shows promising efficacy against recurrent small cell lung cancer (SCLC). The treatment, which combines a novel anti-DLL3 antibody with a powerful anticancer agent, halted tumor growth in 89% of patients with high levels of DLL3 in the tumor and shrank tumors in 39%.

“The study by Rudin et al was presented today at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8505).

“ ‘We’ve seen too few successes in recent years for small cell lung cancer, which makes these early signs of efficacy all the more encouraging,’ said lead study author Charles M. Rudin, MD, PhD, a medical oncologist and Chief of Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center in New York. ‘Although these results are preliminary, rovalpituzumab tesirine seems to be the first targeted therapy to show efficacy in small cell lung cancer, and we may have identified DLL3 as the first predictive biomarker in this disease.’ ”

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ASCO 2016: Nivolumab Alone or in Combination With Ipilimumab Active in Recurrent Small Cell Lung Cancer

Excerpt:

“A study presented by Antonia et al at the 2016 ASCO Annual Meeting (Abstract 100) showed that utilizing the immunotherapeutic agents nivolumab (Opdivo) and ipilimumab (Yervoy) could lead to more effective treatment options for patients with small cell lung cancer (SCLC) who have progressed after prior chemotherapy.

“Studies have shown that nivolumab combined with ipilimumab results in improved antitumor activity when compared with either agent alone. The U.S. Food and Drug Administration recently approved this two-drug combination for the treatment of advanced melanoma.

“Given the promising activity of the immunotherapy combination in melanoma, researchers wanted to assess whether this regimen could also be effective in other types of tumors with few to no therapeutic options.”

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ARIAD Presents Long-Term Phase 1/2 Trial Follow up on Investigational Drug Brigatinib with Median Time on Treatment of 17 Months in ALK+ NSCLC Patients

Excerpt:

ARIAD Pharmaceuticals, Inc.(NASDAQ:ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include more mature efficacy and safety data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients.

“The updated Phase 1/2 results are being presented today at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.”

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New Data Evaluating KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer Demonstrate Response Rates Ranging from 48 to 71 Percent

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from an initial proof-of-concept study of KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, combined with standard treatments, one with bevacizumab and others without, in non-small cell lung cancer (NSCLC) including chemotherapy in previously untreated patients with NSCLC; the study showed overall response rates (ORR) ranging from 48 to 71 percent, depending on the therapy used. These data, from the phase 1/2 KEYNOTE-021 trial, will be presented today at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Shirish Gadgeel of the Barbara Ann Karmanos Cancer Institute (Abstract #9016) from 8:00 – 11:30 a.m. CDT (Location: Hall A) and in a poster discussion from 3:00 – 4:15 p.m. CDT (Location: E354b).

“ ‘Combining KEYTRUDA and chemotherapy in the first-line lung cancer treatment setting is an important part of our effort to develop more treatment options for patients with non-small cell lung cancer,’ said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. ‘This study has helped us to identify chemotherapy options for combination with KEYTRUDA regardless of PD-L1 expression to take forward in phase 3 trials.’ ”

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Nivolumab/Ipilimumab Frontline Response Nears 60% in PD-L1+ NSCLC

Excerpt:

“Upfront treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated an objective response rate (ORR) of 57% in patients with PD-L1-positive advanced non–small cell lung cancer (NSCLC), according to updated pooled findings from the phase Ib CheckMate-012 study presented at the 2016 ASCO Annual Meeting.

“In the 3-arm study, patients received nivolumab alone or in combination with ipilimumab every 6 weeks (Q6W) or every 12 weeks (Q12W). Across the full population, which was not selected based on PD-L1 expression, single-agent nivolumab had an ORR of 23%. In the combination arms, the ORRs were 47% and 39%, in the Q12W and Q6W arms, respectively.”

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One Honest Researcher and More Talk of Cure for Melanoma

Excerpt:

“Which anti-PD-1 immunotherapy should you choose for the treatment of advanced melanoma: nivolumab (Opdivo, Bristol-Myers Squibb) or pembrolizumab (Keytruda, Merck)?

“In a refreshing display of academic impartiality, pembrolizumab investigator Caroline Robert, MD, PhD, from the Institut Gustave-Roussy in Paris, said it doesn’t much matter.

” ‘Honestly, I don’t see any difference,’ she said when asked which drug is superior in terms of efficacy and safety at a presscast held in advance of the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.

“Dr Robert’s candor was trumped by scientific rigor from presscast host and ASCO President Julie Vose, MD, MBA, who is from the University of Nebraska in Omaha.”

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