ASH 2014: Highlights from SCRIP Intelligence.
SCRIP and Datamonitor Healthcare take you through some key highlights from ASH 2014
The 56th ASH Annual Meeting and Exposition took place between 6th-9th December 2014. As the premier event in malignant and non-malignant hematology we’ve put together the top findings from the meeting, sourced from our colleague SCRIP Intelligence. Click on the links below to read the full articles.
Amgen/Onyx’s Kyrolis improves survival, quality of life
Amgen’s Onyx Pharmaceuticals subsidiary reported on 6 December that giving Kyprolis (carfilzomib) to newly-diagnosed multiple myeloma patients on top of Celgene’s Revlimid (lenalidomide) plus dexamethasone reduced the risk of death by 21% and improved quality of life.
New results from the Phase III ASPIRE clinical trial, which were presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco, will support a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the first Kyprolis approval in the EU as well as an application to expand the proteasome inhibitor’s US label and convert the drug’s US FDA approval from accelerated to full approval.
The data presented at ASH expanded on prior top-line results, which showed an 8.7-month median progression-free survival (PFS) benefit (scripintelligence.com, 5 August 2014). Median PFS, the ASPIRE study’s primary endpoint, was 26.3 months for patients treated with Kyprolis, Revlimid and dexamethasone (KRd) versus 17.6 months for Revlimid and dexamethasone (Rd) (p<0.0001).
High Hodgkin’s lymphoma responses for BMS, Merck PD-1 inhibitors
The race between programmed cell death-1 (PD-1) immune checkpoint inhibitors from Bristol-Myers Squibb and Merck & Co continues with promising data for both monoclonal antibodies in Hodgkin’s lymphoma, but Bristol-Myers’s Opdivo (nivolumab) has an overall response rate (ORR) edge over Merck’s Keytruda (pembrolizumab).
It’s difficult to compare data across two small Phase Ib clinical trial cohorts, especially since the Opdivo interim results come from fewer patients than the Keytruda interim analysis, but ORRs were 87% for Opdivo (20 out of 23 patients) and 66% (19 out of 29 patients) for Keytruda in data presented on 6 December at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco.
With an 87% ORR and stable disease for the other 13% of patients in the Bristol-Myers clinical trial, the company’s vice president and global development lead for Opdivo and Yervoy (ipilimumab), Fouad Namouni, noted that all Hodgkin’s lymphoma patients in the Phase Ib study achieved disease control as of the interim analysis reported at ASH.
Takeda’s oral ixazomib succeeds as myeloma maintenance therapy
Ixazomib (MLN9708), Takeda Oncology’s oral follow-on to Velcade (bortezomib), showed in a Phase II clinical trial that the proteasome inhibitor could offer safety and convenience for previously untreated multiple myeloma patients who are in the maintenance phase of treatment.
Takeda Pharmaceutical, which changed the name of its oncology business from Millennium to Takeda Oncology effective 6 December, presented data from the single-agent maintenance stage of its Phase II clinical trial for ixazomib on 7 December at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco. The drug was effective as long-term maintenance therapy and side effects were manageable in patients treated for up to 23 months.
Acceleron drugs improve anemia in blood disorders
Acceleron Pharma’s lead product candidates luspatercept and sotatercept reduced or eliminated transfusion dependence for many patients with beta-thalassemia and myelodysplastic syndromes (MDS), but the company’s partner Celgene is likely to take only one of the two drugs into later-stage development.
Cambridge, Massachusetts-based Acceleron closed up 13.6% at $42.67 per share after data from Phase II clinical trials for luspatercept and sotatercept were presented on 7 and 8 December during the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco. Both drugs target the transforming growth factor-beta (TGF-b) protein superfamily, which regulates blood cell formation. The therapies are designed to boost red blood cell production in order to reduce anemia in beta-thalassemia, MDS and other blood disorders.
COMING SOON: Keep an eye out for our ASH 2014 Post-Conference White Paper. We’ll be publishing this on our website in the next couple of days.
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Posted in Oncology.