MARTINSRIED / MUNICH, Germany I October 17, 2016 I MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) presented updated safety and efficacy data from an ongoing phase 1/2a clinical study evaluating MOR202, an investigational antibody targeting CD38, alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom), plus dexamethasone (Dex) in heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). Data were presented during a poster presentation at the 2016 annual meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology in Leipzig/Germany.
Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG, commented: “We are very pleased that these results are consistent with earlier data from the ongoing trial and show further improved responses with more patients being evaluable for efficacy and safety assessment. In addition to the very short infusion-time, we are particularly interested in the efficacy results in patients treated with MOR202 plus pomalidomide, who had a median of four prior therapies. The dose escalation study is ongoing as planned, currently focusing on the highest dose cohorts of 16 mg/kg MOR202 in combination with pomalidomide and lenalidomide.”
78 % of evaluable patients (7 out of 9) treated with MOR202 in combination with Len/Dex showed an objective response (i.e. complete response (CR) or partial response (PR)). In the patient group treated with MOR202 plus Pom, 60 % (3 out of 5) showed an objective response, with two patients achieving a complete remission (CR). Considering only patients enrolled per protocol, the ORR (objective response rate) in this patient group rises to 75 % and the CR rate to 50 %. Of the patients treated with MOR202 alone, so far 29 % (5 out of 17) showed an objective response. Median time to response was six weeks with most responses deepening over time. 12 of the 15 responses are currently ongoing for up to 56 weeks.
When MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg, 92 % of patients treated showed no infusion-related reactions (IRRs). IRRs occurred in just 8 % of patients (3 % of grade 1, 5 % of grade 2) and were mainly limited to the first infusion. No unexpected safety signals were observed. The most frequent adverse events of grade 3 or higher were, as expected, hematological and included lymphopenia, neutropenia and leukopenia. No treatment-related deaths were reported.
Biomarker data on bone marrow plasma cells suggests that during MOR202 therapy, expression of CD38 as the target molecule for MOR202 seems to be preserved.
The poster presented at the DGHO Annual Meeting can be downloaded from the Company’s website.
About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma. Data are from an ongoing clinical phase 1/2a, open-label, multi-center, dose-escalation study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 alone and in combination with the immunomodulatory drugs pomalidomide (Pom) and lenalidomide (Len) plus dexamethasone (Dex) in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 alone and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.
About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer’s disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
SOURCE: Morphosys
Post Views: 172
MARTINSRIED / MUNICH, Germany I October 17, 2016 I MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) presented updated safety and efficacy data from an ongoing phase 1/2a clinical study evaluating MOR202, an investigational antibody targeting CD38, alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom), plus dexamethasone (Dex) in heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). Data were presented during a poster presentation at the 2016 annual meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology in Leipzig/Germany.
Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG, commented: “We are very pleased that these results are consistent with earlier data from the ongoing trial and show further improved responses with more patients being evaluable for efficacy and safety assessment. In addition to the very short infusion-time, we are particularly interested in the efficacy results in patients treated with MOR202 plus pomalidomide, who had a median of four prior therapies. The dose escalation study is ongoing as planned, currently focusing on the highest dose cohorts of 16 mg/kg MOR202 in combination with pomalidomide and lenalidomide.”
78 % of evaluable patients (7 out of 9) treated with MOR202 in combination with Len/Dex showed an objective response (i.e. complete response (CR) or partial response (PR)). In the patient group treated with MOR202 plus Pom, 60 % (3 out of 5) showed an objective response, with two patients achieving a complete remission (CR). Considering only patients enrolled per protocol, the ORR (objective response rate) in this patient group rises to 75 % and the CR rate to 50 %. Of the patients treated with MOR202 alone, so far 29 % (5 out of 17) showed an objective response. Median time to response was six weeks with most responses deepening over time. 12 of the 15 responses are currently ongoing for up to 56 weeks.
When MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg, 92 % of patients treated showed no infusion-related reactions (IRRs). IRRs occurred in just 8 % of patients (3 % of grade 1, 5 % of grade 2) and were mainly limited to the first infusion. No unexpected safety signals were observed. The most frequent adverse events of grade 3 or higher were, as expected, hematological and included lymphopenia, neutropenia and leukopenia. No treatment-related deaths were reported.
Biomarker data on bone marrow plasma cells suggests that during MOR202 therapy, expression of CD38 as the target molecule for MOR202 seems to be preserved.
The poster presented at the DGHO Annual Meeting can be downloaded from the Company’s website.
About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma. Data are from an ongoing clinical phase 1/2a, open-label, multi-center, dose-escalation study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 alone and in combination with the immunomodulatory drugs pomalidomide (Pom) and lenalidomide (Len) plus dexamethasone (Dex) in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 alone and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.
About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer’s disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
SOURCE: Morphosys
Post Views: 172
