Significant improvement in Overall Response Rate (83%) compared with matched case control group (45%).
Significant overall survival advantage, with a 46% reduction in the risk of death.
Excellent safety profile and significant efficacy bolster HaemaLogiX's plan to progress further KappaMab / standard of care combination studies.
SYDNEY, June 29, 2023 /PRNewswire/ -- HaemaLogiX Ltd, a clinical stage Australian biotech company developing novel immunotherapies for multiple myeloma, today announced positive final results from a Phase IIb clinical study of its monoclonal antibody KappaMab in combination with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatment options. The final data has been published in the British Journal of Haematology. Key findings include:
The median Overall Survival was not reached, with two patients remaining on therapy and continuing to respond, and with no evidence of detectable disease.
KappaMab's previously established safety profile was reaffirmed, with no KappaMab related haematological toxicities or serious adverse effects. The phase IIb study was initiated off the back of phase I, IIa, and preclinical data suggesting KappaMab may have a synergistic mechanism of action with lenalidomide, a drug sold under the trade name Revlimid®, that forms standard of care for multiple myeloma. Lenalidomide is administered as both a monotherapy and with other drugs including dexamethasone, depending on the treatment approach and disease status. "This study validates KMA as a highly specific target, and the ability to safely deliver KappaMab in combination with a mainstay treatment for multiple myeloma," HaemaLogiX CEO, Bryce Carmine, said: "We are tremendously grateful to the investigators and to the patients who participated.
"We look forward to furthering the clinical progress of KappaMab with a clinical trial at a higher dose of KappaMab which will flow into a Phase IIb study investigating KappaMab in combination with pomalidomide and dexamethasone in patients who have relapsed or become refractory to other standard of care treatments." This Phase IIb trial followed a Phase IIa open-label multiple dose trial to determine the safety and efficacy of multiple doses of KappaMab monotherapy in 19 relapsed and / or refractory patients who had received multiple prior treatments. The phase IIb trial was a multi-centre trial led by Professor Andrew Spencer, which evaluated patient responses to KappaMab when combined with standard of care treatment compared to the standard of care drugs alone. The trial enrolled 40 patients with kappa-type myeloma who had previously been treated with one to three lines of drugs, and in which the disease was progressing. Along with positive efficacy results, the trial demonstrated an excellent safety profile with no patients experiencing KappaMab related serious side effects.