Top Pharma News – June 2016

Astellas and Seattle Genetics Present ASG-15ME and ASG-22ME Phase I Clinical Data in Metastatic Urothelial Cancer


June 6, 2016

Astellas Pharma Inc. and Seattle Genetics, Inc. (NASDAQ: SGEN) have presented first clinical data for ASG-15ME and ASG-22ME at the American Society of Clinical Oncology (ASCO) 51st Annual Meeting that was held in June 3-7, 2016 in Chicago, IL.


Pfizer Announces Positive Top-Line Results from Second Phase 3 Trial of Oral XELJANZ® (Tofacitinib Citrate) In Adults with Psoriatic Arthritis


June 7, 2016

Pfizer Inc. has announced top-line results from Oral Psoriatic Arthritis trial (OPAL) Beyond. This is the second Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA). This study assessed the safety and efficacy of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active Psoriatic Arthritis who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi), making it the first PsA study for focusing exclusively on TNFi-IR patients. Primary efficacy endpoints were met by OPAL Beyond, demonstrating a statistically significant (p<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compared to placebo treatment as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months and response by American College of Rheumatology 20 (ACR20).


New Data on Opdivo (nivolumab) from Bristol-Myers Squibb Indicate Benefit in Heavily Pre-Treated Classical Hodgkin Lymphoma Patients


June 10, 2016

Bristol-Myers Squibb Company has announced results from CheckMate -205, a multi-cohort, single-arm, non-comparative, Phase 2 registrational trial evaluating Opdivo (nivolumab) in classical Hodgkin lymphoma (cHL) patients. The results included patients who had relapsed or progressed after post-transplantation brentuximab vedotin and autologous hematopoietic stem cell transplantation (auto-HSCT). The primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC) was 66.3% (95% CI: 54.8-76.4). Median time to response was 2.1 months, and estimated median duration of remission was 7.8 months (95% CI: 6.6-NE). In an exploratory analysis, it was observed that over two-thirds (72.1%) of patients who did not respond to most recent prior brentuximab vedotin treatment did respond to Opdivo.


Celgene and Acceleron Announce Updated Results from an Ongoing Phase 2 Study of Luspatercept in Myelodysplastic Syndromes 

celgene and acceleron

Jun 10, 2016

Celgene Corporation and Acceleron Pharma Inc. has announced preliminary results from an ongoing long-term Phase 2 extension study with luspatercept in patients with lower risk myelodysplastic syndromes (MDS). Results were declared at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark. Results of the study showed that 51% of patients with lower risk MDS treated with luspatercept (n=49) achieved increased hemoglobin levels and 35% of patients achieved transfusion independence in the 3-month base study. In the ongoing extension study, 81% (26/32) of patients had increased hemoglobin levels and of the patients eligible for transfusion independence (TI), 50% achieved TI with luspatercept treatment. This Luspatercept is being developed as part of the global collaboration between Celgene and Acceleron.


Novartis announces long-term safety data of Revolade® in adults with chronic immune thrombocytopenia


June 10, 2016

Novartis has announced data from the largest study of its kind confirming the long-term safety profile of Revolade (eltrombopag) in adults suffering from chronic immune (idiopathic) thrombocytopenia (ITP), with data for up to 6 years in some patients (median exposure was 2.4 years). More data from the study would also show that long-term oral administration of Revolade was effective in increasing and maintaining platelet counts in adult patients who had their spleens removed (splenectomized) as well as those who did not (non-splenectomized). Final results of the study and sub-analysis will be presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.


BLINCYTO® (Blinatumomab) Improved Overall Survival in Patients with B-Cell Precursor Acute Lymphoblastic Leukemia


June 10, 2016

Amgen has announced new data from an interim analysis of the Phase 3 TOWER study, in which BLINCYTO® (blinatumomab) confirmed nearly two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study estimated the effectiveness of BLINCYTO versus SOC chemotherapy in adult patients with Philadelphiachromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Results from the analysis showed that median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO compared to 4 months (95 percent CI: 2.9, 5.3) for SOC (stratified log-rank test p=.012; hazard ratio=0.71).


New Results from Pivotal Phase 3 Studies Show that Kyprolis® (Carfilzomib) Allows Patients with Relapsed Multiple Myeloma to Live Longer


June 10, 2016

Amgen has announced results from a post-hoc analysis of the pivotal Phase 3 ASPIRE study which emphasized the advantages of continued treatment with Kyprolis® (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. Furthermore, separate sub-analyses of the Phase 3 ENDEAVOR study confirmed depth and efficacy of response benefits of Kyprolis plus dexamethasone (Kd). These results were presented at the 21st Congress of the European Hematology Association (EHA).


Data presented by Novartis showing Jakavi® is superior to best available therapy in patients with less advanced polycythemia vera (PV)


June 10, 2016

Novartis has announced Phase III data from RESPONSE-2 revealing that Jakavi®(ruxolitinib) assisted patients with polycythemia vera (PV), who were resistant to or intolerant of hydroxyurea and did not have an enlarged spleen, achieve superior hematocrit control compared to best available therapy (BAT) at 28 weeks (62.2% vs 18.7%, respectively; p<0.0001). These findings were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark for the first time.


Final Results Announced by Pfizer from Inotuzumab Ozogamicin Pivotal Phase 3 Study in Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia


June 12, 2016

Pfizer Inc. has announced the publication of findings from the Phase 3 INO-VATE ALL study in The New England Journal of Medicine’s online issue. This study, also known as Study 1022, is a randomized, open-label, Phase 3 study evaluating the efficacy and safety of inotuzumab ozogamicin as compared with investigator-choice chemotherapy in 326 adult patients with refractory or relapsed CD22-positive acute lymphoblastic leukemia (ALL). Results of the study showed improvement over chemotherapy on a number of measures including progression-free survival (PFS) and complete hematologic remission.


KEYTRUDA® (pembrolizumab) of Merck Receives Positive CHMP Opinion for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)


June 27, 2016

Merck, known as MSD outside the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have received at least one prior chemotherapy regimen and whose tumors express PD-L1. This CHMP positive opinion for KEYTRUDA will now be reviewed by the European Commission for marketing authorization in the European Union (EU).


EMA and FDA accept Marketing applications of Roche for review of OCREVUS® (ocrelizumab) in two forms of multiple sclerosis


28 June 2016

Roche has announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) of OCREVUS® (ocrelizumab) in the European Union (EU) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This Validation confirms that the submission is complete and signifies the MAA is under review by the Committee for Medicinal Products for Human Use (CHMP) of EMA. The U.S. Food and Drug Administration (FDA) has also accepted for review the Biologics License Application (BLA) of Roche for OCREVUS for the treatment of RMS and PPMS, and has granted the application Priority Review Designation with a targeted action date of 28 December 2016. OCREVUS would be the first and only treatment for both forms of multiple sclerosis (MS) if approved by the EMA and FDA for both indications, which affect approximately 95 percent of people at diagnosis.


Top Pharma News – June 2016 last edit: 2016-07-06T18:36:22+00:00 da Luca

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