New Cohorts from CheckMate -012 Assess Optimal Dosing of Opdivo+Yervoy in the First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

“Bristol-Myers Squibb Company (NYSE:BMY) today announced updated results from the Opdivo (nivolumab)+Yervoy (ipilimumab) arms in CheckMate -012, a multi-arm Phase 1b trial evaluating Opdivo in patients with chemotherapy-naïve advanced non-small cell lung cancer (NSCLC). In this study, Opdivo was administered as monotherapy or as part of a combination with other agents, including Yervoy, at different doses and schedules. Results from other cohorts in CheckMate -012 have been previously-unreported. These updated results include findings from the administration of four new dosing schedules of Opdivo+Yervoy (n=148), which resulted in confirmed objective response rates (ORR) ranging from 13% to 39% depending on the administered regimen. Median duration of response was not reached in any of these arms with a median follow-up of 6.2 months to 16.6 months, and median progression-free survival (PFS) ranged from 4.9 months to 10.6 months.”


PharmaMar's Investigational Drug PM1183 plus Doxorubicin Shows Remarkable Activity in Small Cell Lung Cancer

“PharmaMar today announced data from a Phase 1b study of the transcriptional inhibitor PM1183 in combination with doxorubicin in second line therapy in patients with small cell lung cancer (SCLC) showing that the treatment induced objective responses in 67% of the patients, including 10% of them where all signs of cancer disappeared (complete responses). Every patient with SCLC denominated primary chemotherapy-sensitive (their chemotherapy-free interval (CTFI) is more than 90 days) responded to treatment, including 18% of complete responses. In primary chemotherapy-resistant patients, where cancer was progressing within 90 days or less of previous chemotherapy, a remarkable 30% achieved a response. Notably, the treatment resulted in durable responses, with an overall progression-free survival (PFS) of 4.6 months, which was 3.6 months in resistant patients. The most common adverse drug reaction was reversible myelosuppresion but no cardiotoxicity or drug-related deaths were observed.

“ ‘The rate, depth and length of responses that we have observed with this treatment in the second-line setting are remarkable, even in those patients that are usually considered harder to treat”, said Dr. Martin Forster, University College Hospital, London, UK.

“ ‘Small cell lung cancer is an unmet clinical need with very few recent advances and the scientific community is committed to help new develop effective therapies.’ ”


Aduro Announces ASCO Presentation of Promising Results from Phase 1b Clinical trial of its Novel Immunotherapy for the Treatment of Mesothelioma

“Aduro BioTech, Inc., a clinical stage biotechnology company, today announced the presentation of safety and efficacy data from a Phase 1b clinical trial of its novel immunotherapy CRS-207 in combination with standard chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM). Of the 16 evaluable patients, 69% (11/16) had confirmed durable partial responses (PR) with 25% (4/16) experiencing stable disease (SD) after CRS-207 and chemotherapy. The results were presented by Raffit Hassan, M.D., co-chief of the Thoracic and GI Oncology Branch at the National Cancer Institute, in a poster presentation at the 2014 American Society of Clinical Oncology Meeting (ASCO) held in Chicago.”

Editor’s note: Scientists have developed a new drug called CRS-207 for treating mesothelioma. CRS-207 is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. A clinical trial testing CRS-207 in volunteer patients found promising results for the drug.


Two Array-Invented MEK Inhibitors Showcased At ASCO

“Two Array BioPharma-invented MEK inhibitors, binimetinib (MEK162) and selumetinib, were showcased at the 50th annual meeting of the American Society of Clinical Oncology (ASCO).  At the meeting, preliminary data for the combination of binimetinib and CDK4/6 inhibitor LEE011 (discovered by Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals) from a Phase 1b/2 dose-escalation study conducted by Novartis in NRAS-mutant melanoma indicates the combination demonstrated an acceptable safety profile for most patients with promising preliminary antitumor activity.  Additionally, preliminary data for selumetinib showed favorable clinical activity in pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs).”

Editor’s note: This article discusses a melanoma treatment that combines two durgs: binimetinib (aka MEK162) and selumetinib. A clinical trial recently found that the combo shows promise for melanoma patients whose tumors have mutations in the NRAS gene, as detected by molecular testing. Binimetinib is also being tested as a potential treatment for patients whose tumors have mutations in the BRAF gene.