The class of cancer immunotherapy drugs which target the protein PD-1 is proving to be effective against advanced liver, head and neck, lung and colon cancers.
Merck's Keytruda demonstrated a 62% tumor shrinkage in patients with advanced colon cancer containing a newly discovered genetic biomarker.The tumor response rate to Bristol's Opdivo in patients with advanced liver cancer was 19%. The overall survival rate at 12 months was 62%. While early, the results suggest Opdivo may have a role to play in the treatment of the disease where only a single targeted drug has proven effective.In a study of patients with head and neck cancer, Merck's Keytruda demonstrated a tumor response rate of 25%, or more than double the response typically seen with Eli Lilly's Erbitux.In the only randomized study discussed Friday enrolling patients with advanced, non-squamous, non-small cell lung cancer (the most common form of lung cancer) treatment with Bristol's Opdivo led to a 27% reduction in the risk of death compared to a placebo. Patients with tumors expressing high levels of the protein PD-1 lived even longer.
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new investigational data evaluating KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy from the KEYNOTE-012 Phase 1b study in 132 pre-treated patients with recurrent or metastatic head and neck cancer, regardless of PD-L1 expression status. In the evaluable patients, the overall response rate (ORR) (confirmed and unconfirmed) was 24.8 percent for KEYTRUDA (200 mg fixed dose every three weeks) (n=29/117) (95% CI, 17.3-33.6). When looking at HPV status, the ORR was similar among HPV-positive and HPV-negative disease (20.6 percent [n=7/34] and 27.2 percent [n=22/81], respectively) (95% CI, 8.7-37.9 and 17.9-38.2). These data, featured in the ASCO Press Program today, will be presented in an oral session by Dr. Tanguy Seiwert, The University of Chicago, on Monday, June 1 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (Abstract #LBA6008).
Merck has initiated a comprehensive clinical development program for KEYTRUDA evaluating a fixed dosing regimen (200 mg every three weeks) in head and neck cancer across multiple lines of therapy as monotherapy and in combination with chemotherapy and other agents. Results from KEYNOTE-012 were first presented at the 2014 ASCO Annual Meeting and showed 19.6 percent ORR for KEYTRUDA (10 mg/kg every two weeks) in heavily pre-treated patients with advanced head and neck cancer with tumor cells positive for PD-L1 expression.
KEYNOTE-012 is an ongoing multi-center, non-randomized Phase 1b trial evaluating the safety, tolerability and anti-tumor activity of KEYTRUDA monotherapy (10 mg/kg every two weeks or 200 mg IV every three weeks) in patients with advanced triple negative breast cancer (TNBC), advanced head and neck cancer, advanced urothelial cancer, or advanced gastric cancer. The primary endpoints of the study include overall safety, tolerability, and anti-tumor activity (as measured by RECIST v1.1); secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response.
Merck MRK, known as MSD outside the United States and Canada, announced today that in November and December, data will be presented for the first time investigating the use of KEYTRUDA® (pembrolizumab) – the company’s anti-PD-1 therapy – in advanced melanoma in comparison to chemotherapy, and in relapsed/refractory classical Hodgkin Lymphoma (cHL) as well as advanced triple negative breast cancer (TNBC). These studies will be presented in oral sessions at the Society for Melanoma Research (SMR) 2014 International Congress, Nov. 13 – 16, the 56th American Society of Hematology (ASH) Annual Meeting, Dec. 6 – 9, and the San Antonio Breast Cancer Symposium (SABCS), Dec. 9 – 13, respectively. By the end of 2014, data on anti-tumor activity of KEYTRUDA as monotherapy will have been presented in seven different tumor types.
AstraZeneca and MedImmune, the company’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.
Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumour types and tumour biology.
Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.
MEDI4736 and tremelimumab target two different tumour escape pathways; engaging the immune system to fight the cancer’s immune-evading tactics and maintaining tumour specific T-cell responses.
Data from the Phase Ib open label, dose escalation study of patients with advanced NSCLC, showed that the combination of the PD-L1 and CTLA-4 blockade helped to increase response rates in both PD-L1 biomarker positive and negative patients. 63 patients with 16 weeks or more of follow up were evaluable for clinical activity, 102 patients were evaluated for safety. Notably, the data demonstrated specific clinical activity and tolerability in PDL-1 negative patients, who make up approximately 70% of NSCLC patients and who are less likely to respond to monotherapy. In the PD-L1 negative patient subset, overall response rate (ORR) was 27% (9/33) and disease control rate (DCR) – defined as complete response (CR), partial response (PR) or stable disease (SD) for 16 weeks or more - was 48% (16/33). Overall, nearly half of patients in the study achieved a partial response or stable disease, with ORR of 27% (17/63) and DCR of 41% (26/63). (Antonia et al, abstract #3014).
Seattle Genetics Announces Clinical Data Presentations from Multiple Antibody-Drug Conjugate (ADC) Programs at ASCO Annual Meeting
BOTHELL, Wash.--(BUSINESS WIRE)--May 28, 2015-- Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that data from multiple proprietary and collaborator antibody-drug conjugate (ADC) programs will be highlighted in more than 10 sessions at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting being held May 29 to June 2, 2015 in Chicago, IL. Presentations will feature data from several corporate and investigator-sponsored trials with ADCETRIS® (brentuximab vedotin), including additional analyses from the phase 3 AETHERA clinical trial and updated data in frontline diffuse large B-cell lymphoma (DLBCL). In addition, the company’s ADC collaborators, including Genentech (a member of the Roche Group), AbbVie, Genmab and Agensys (an affiliate of Astellas), will report data from clinical programs using Seattle Genetics’ ADC technology. Seattle Genetics will also present preclinical data from its novel SEA-CD40 immuno-oncology candidate currently being evaluated in a phase 1 clinical trial.
Seattle Genetics is evaluating its ADC technology broadly through ADCETRIS, proprietary pipeline and collaborator programs. The company is leading the field in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition, Seattle Genetics is building on expertise in empowered, targeted approaches for the treatment of cancer in advancing its proprietary sugar-engineered antibody (SEA) technology, a novel technology designed to increase the potency of monoclonal antibodies through glycoengineering which may lead to an improved antitumor immune response.
SOUTH SAN FRANCISCO, Calif., May 29, 2015 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals(Nasdaq:PTLA) today announced updated positive safety and efficacy data from the Phase 1 part of its ongoing Phase 1/2a proof-of-concept study of cerdulatinib in patients with hematologic cancers who have failed multiple therapies. Cerdulatinib is an oral, dual Syk-JAK kinase inhibitor that Portola is developing to treat patients with hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies. The new data will be presented on Sunday, May 31, in a poster discussion session at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting inChicago. The Company previously presented interim data from the Phase 1 part of the study at theAmerican Society of Hematology (ASH) 2014 Annual Meeting in December 2014.
The results to be presented at ASCO demonstrated evidence of clinical activity in this study of patients with relapsed/refractory B-cell malignancies. To date, partial responses have been observed, including in patients with chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and transformed FL. Tumor reductions were seen in multiple patients, including those whose disease progressed on (or who could not tolerate) other BCR pathway inhibitors. Results also showed that cerdulatinib was well tolerated in these heavily pre-treated patients, with no dose-limiting toxicities identified. Grade 3/4 adverse events included fatigue. Dose-escalation is ongoing in the Phase 1 part of the study as the maximum tolerated dose has not yet been achieved.
The FDA’s approval in 2010 of the blood-thinner dabigatran (Pradaxa) got many doctors excited. This drug got the green light after a head-to-head trial with warfarin (generic, Coumadin) in people with an irregular heart beat from atrial fibrillation.
Importance It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice.
Objective To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data.
Design, Setting, and Participants In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011.
Main Outcomes and Measures We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities.
Results Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease.
Conclusions and Relevance Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.
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