Articles tagged with: Clinical Trial Results
Press Releases»
Enrollment to cease immediately; topline data anticipated in H1 2021
Tel Aviv, Israel (Press Release) – BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.
At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient …
Press Releases»
- Second part of the Phase 3 CASSIOPEIA study of daratumumab as maintenance treatment for patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant met the primary endpoint of progression-free survival at a pre-planned interim analysis
- Independent Data Monitoring Committee recommends unblinding the study results
- Based on the data, Janssen plans to discuss the potential for a regulatory submission with health authorities
Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today positive topline results from the second part of the Phase 3 CASSIOPEIA (MMY3006) study of daratumumab monotherapy as maintenance treatment versus observation (no treatment) for patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT). The second part of the study, which is being conducted by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and …
Press Releases»
TOURMALINE-MM2 Data Presented Virtually at the Society of Hematologic Oncology (SOHO) Eighth Annual Meeting
Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from the Phase 3 TOURMALINE-MM2 trial evaluating the addition of NINLARO™ (ixazomib) to lenalidomide and dexamethasone versus lenalidomide and dexamethasone plus placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant. These data will be presented at the virtual scientific meeting of the Society of Hematologic Oncology (SOHO) on Wednesday, September 9, 2020 at 6:15 p.m. CT.
The study found the addition of NINLARO to lenalidomide and dexamethasone resulted in a 13.5 …
Press Releases»
40% overall response rate (ORR) with a total administered dose of 60 mCi or greater
Forham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that a clinically meaningful 40% overall response rate (ORR) was observed in the subset of refractory multiple myeloma patients deemed triple class refractory who received a total administered dose of 60 mCi or greater. Triple class refractory is defined as patients refractory to immunomodulatory, proteasome inhibitors and anti-CD38 antibody drug classes.
The 40% ORR (6/15 patients) represents triple class refractory …
Press Releases»
- TTI-622 (SIRPa-IgG4 Fc) completed 8 mg/kg safety assessment in the ongoing dose escalation study in relapsed / refractory lymphoma; now escalating to 12 mg/kg dose level.
- TTI-622 monotherapy shows 6/18 (33%) objective responses at 0.8 to 8 mg/kg dose levels, including 3/6 (50%) objective responses at 8 mg/kg.
- TTI-621 (SIRPa-IgG1 Fc) well tolerated at 1.4 mg/kg; continues to show monotherapy signal and dose-dependent improvement in skin disease scores in the ongoing dose escalation study in relapsed / refractory CTCL.
- Trillium to host conference call at 5:30 p.m. ET today
Cambridge, MA (Press Release) – Trillium Therapeutics Inc. (“Trillium” or the “Company”) (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, today announced updated data from its ongoing TTI-622 and TTI-621 dose escalation studies.
“We are exceedingly encouraged by the evolving profile of TTI-622, our SIRPa-IgG4 Fc fusion protein, as demonstrated in the ongoing dose escalation study in relapsed and refractory lymphomas,” said Jan Skvarka, Trillium’s President and Chief Executive Officer. “TTI-622 is showing substantial …
Press Releases»
- Phase 3 APOLLO randomized study evaluating subcutaneous daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in relapsed or refractory multiple myeloma met the primary endpoint of improving progression-free survival
- Janssen intends to discuss the data with health authorities for potential regulatory submissions
Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today that the European Myeloma Network (EMN) in collaboration with Janssen Research & Development, LLC (Janssen) reported positive results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous (SC) formulation of daratumumab in combination with pomalidomide and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI). The study met the primary …
Press Releases»
- IKEMA trial results released early based on recommendation of an Independent Data Monitoring Committee
- Addition of Sarclisa significantly reduced the risk of disease progression or death compared to carfilzomib and dexamethasone alone
- Results will be submitted to an upcoming medical meeting and form the basis for regulatory submissions later this year
Paris, France (Press Release) – The Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma. There were no new safety signals identified in this study.
“When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase 3 trial, results clearly demonstrated a significant reduction in …