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MOR202 (8 mg/kg) plus Pom/Dex in relapsed/refractory multiple myeloma (MM) patients shows two complete responses (CR) and two minor responses (MR) (one of which is unconfirmed) out of five patients
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MOR202 (8 mg/kg) plus Len/Dex in MM shows two partial responses (PR) and one very good partial response (VGPR) out of the four patients in this combination cohort with a scheduled response assessment after one treatment cycle
-
First biomarker data suggest that CD38 expression on MM patient bone marrow plasma cells was preserved during MOR202 therapy
-
MOR202 administered in doses of up to 16 mg/kg as a 2-hour intravenous infusion with low incidence of infusion-related reactions (IRR)
-
MOR208 shows disease control rate (CR + PR + SD) of 40% in relapsed/refractory diffuse large cell B cell lymphoma (DLBCL) and 73% in indolent non-Hodgkin’s lymphoma (iNHL) patients and duration of response (CR or PR) of up to 26 months (responses ongoing)
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MOR208 leads to reduction in target lesion size also in patients with stable disease (SD)
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MOR208 shows similar progression-free survival (PFS) in rituximab-refractory and non-refractory patients
MARTINSRIED and MUNICH, Germany I June 6, 2016 I MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today presented updated safety and efficacy data from an ongoing clinical phase 1/2a study evaluating the anti-CD38 antibody MOR202 alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom) plus dexamethasone (Dex) in 63 heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). Data were reported during a poster presentation at the 2016 ASCO Annual Meeting. The updates compared to the last presentation of data from this ongoing trial in December 2015 refer in particular to the combination cohorts of MOR202 (8 mg/kg) plus IMiDs.
In the five-patient cohort receiving 8 mg/kg MOR202 in combination with Pom/Dex, two patients reached a complete response (CR) and two patients a minor response (MR) (one of which is unconfirmed). Among the four patients treated with 8 mg/kg MOR202 in combination with Len/Dex and with a scheduled response assessment after one treatment cycle, two reached a partial response (PR) and one a very good partial response (VGPR).
MOR202 could be given in doses of up to 16 mg/kg as a 2-hour infusion to all patients. Infusion-related reactions (IRRs) were observed in 14% of evaluated patients (10% grade 1, 4% grade 2) and were mainly limited to the first infusion.
Moreover, first biomarker data on CD38 expression on plasma cells derived from bone marrow of all five MM patients with available second biopsies, suggested that the CD38 target molecule was preserved during MOR202 therapy comparing values at baseline and at cycle 2 day1.
“We are very pleased with the updated clinical results for MOR202 in multiple myeloma, in particular with two complete responses out of five patients treated with MOR202 plus Pom/Dex. Since we last reported data in December 2015, new and deep responses have been reported with MOR202 in combination with IMiDs. On the safety side, we were pleased to observe that MOR202 could be given to all patients in a 2-hour infusion time, with infusion-related reactions of grade 1 and 2 in only 14% of patients,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. “The dose escalation study will continue as planned, focusing on the combination treatment, in particular the upcoming cohorts of 16mg/kg MOR202 plus Pom/Dex and Len/Dex.”
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.
MOR208: Updated results confirm responses. Subgroup analysis shows target lesion shrinkage in patients with stable disease and activity of MOR208 independent of the response to a prior rituximab treatment
In addition, MorphoSys today presented updated clinical data including a subgroup analysis of a phase 2a study with the anti-CD19 antibody MOR208 in relapsed/refractory patients with various subtypes of non-Hodgkin’s lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL). All patients had received at least one prior rituximab-containing therapy.
According to the subgroup analysis data presented today, in addition to patients achieving a partial or complete response (PR, CR), a clinical benefit was also observed in other patients treated with MOR208. The majority of patients (5/6 DLBCL and 12/16 iNHL) with stable disease (SD) also had a reduction in the size of the target lesions – despite the short treatment period of 3 cycles according to protocol. This resulted in a disease control rate of 40% in DLBCL and 73% in iNHL patients. Moreover, progression-free survival (PFS) with MOR208 therapy was observed to be comparable in rituximab refractory and non-refractory NHL patients (median PFS 5.3 versus 6.6 months, HR 0.85, 95% CI 0.45-1.6, p=0.59). Thus, MOR208 has demonstrated in this trial activity independent of the response to a prior anti-CD20 therapy. Updated data for the overall trial population furthermore revealed that after 12 months the PFS rate was 40% in both DLBCL and iNHL patients. Nine patients treated with MOR208 are still in remission (7 CRs, 2 PRs), the longest responses currently ongoing for 26 months.
“We are very happy with the updated clinical trial results with MOR208,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. “We are impressed by the duration of responses of up to 26 months with MOR208 as a single-agent in heavily pre-treated patients with relapsed/refractory NHL. We were further pleased to observe a decline in the size of the tumor lesions in many in the subgroup of patients with stable disease even when treated for a short period of 3 cycles only. Overall, the updated clinical data presented at ASCO strongly support our strategy to develop MOR208 in B cell malignancies, in particular our planned combination trials in DLBCL and CLL.”
MOR208 is an anti-CD19 antibody with a proprietary modification to the Fc portion in clinical development to treat B cell malignancies. The open-label, phase 2a, multicenter study was designed to assess the activity and safety of weekly doses of 12 mg/kg MOR208 as a single agent in 92 pre-treated patients with various subtypes of relapsed/refractory NHL patients. According to the data observed, MOR208 showed a low level of infusion reactions. The overall response rate (ORR) of MOR208 reached 36% in the DLBCL subgroup and 33% in iNHL patients (both based on evaluable patients). Based on all patients with DLBCL and iNHL in the study, the ORR was 26% and 29%, respectively.
In addition, the trial design of a phase 2 study of MOR208 (COSMOS trial) was presented at the ASCO 2016 Annual Meeting. The trial is planned to evaluate MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), in patients no longer responding to or no longer tolerating Bruton’s tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib). After the discontinuation of several combination trials of idelalisib with other compounds, this planned trial is currently under review and discussions with regulatory authorities are ongoing. MorphoSys is currently exploring alternative study designs to evaluate MOR208 in a combination trial in CLL/SLL patients previously treated with a BTK inhibitor.
The posters presented at the Annual ASCO Meeting, June 6, 2016, 8:30 am CDT (2:30 pm BST, 3:30 pm CEST), can be downloaded from the Company’s website.
Abstract #8012
M. Raab et al: MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed or refractory multiple myeloma: Data from clinically relevant cohorts from a phase 1/2a study.
Abstract #7545
W. Jurczak et al: Subgroup analyses of diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma cohorts from a phase 2a study of single-agent MOR208 in patients with relapsed or refractory non-Hodgkin’s lymphoma (R-R NHL).
Abstract #TPS7572
C.-M. Wendtner et al: A phase 2 study of MOR208 plus idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor.
MorphoSys will hold on June 6, 2016 at 6:30 p.m. CDT (June 7, 2016 0:30 a.m. BST, 1:30 a.m. CEST) an Investor & Analyst Event at the 2016 ASCO Annual Meeting. KOLs will present the new clinical data for MOR208 and MOR202. A replay and the presentation will be made available at http://www.morphosys.com. Live-Webcast: http://morphosys.equisolvewebcast.com/investor-event-6-6-16
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: 58
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MOR202 (8 mg/kg) plus Pom/Dex in relapsed/refractory multiple myeloma (MM) patients shows two complete responses (CR) and two minor responses (MR) (one of which is unconfirmed) out of five patients
-
MOR202 (8 mg/kg) plus Len/Dex in MM shows two partial responses (PR) and one very good partial response (VGPR) out of the four patients in this combination cohort with a scheduled response assessment after one treatment cycle
-
First biomarker data suggest that CD38 expression on MM patient bone marrow plasma cells was preserved during MOR202 therapy
-
MOR202 administered in doses of up to 16 mg/kg as a 2-hour intravenous infusion with low incidence of infusion-related reactions (IRR)
-
MOR208 shows disease control rate (CR + PR + SD) of 40% in relapsed/refractory diffuse large cell B cell lymphoma (DLBCL) and 73% in indolent non-Hodgkin’s lymphoma (iNHL) patients and duration of response (CR or PR) of up to 26 months (responses ongoing)
-
MOR208 leads to reduction in target lesion size also in patients with stable disease (SD)
-
MOR208 shows similar progression-free survival (PFS) in rituximab-refractory and non-refractory patients
MARTINSRIED and MUNICH, Germany I June 6, 2016 I MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today presented updated safety and efficacy data from an ongoing clinical phase 1/2a study evaluating the anti-CD38 antibody MOR202 alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom) plus dexamethasone (Dex) in 63 heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). Data were reported during a poster presentation at the 2016 ASCO Annual Meeting. The updates compared to the last presentation of data from this ongoing trial in December 2015 refer in particular to the combination cohorts of MOR202 (8 mg/kg) plus IMiDs.
In the five-patient cohort receiving 8 mg/kg MOR202 in combination with Pom/Dex, two patients reached a complete response (CR) and two patients a minor response (MR) (one of which is unconfirmed). Among the four patients treated with 8 mg/kg MOR202 in combination with Len/Dex and with a scheduled response assessment after one treatment cycle, two reached a partial response (PR) and one a very good partial response (VGPR).
MOR202 could be given in doses of up to 16 mg/kg as a 2-hour infusion to all patients. Infusion-related reactions (IRRs) were observed in 14% of evaluated patients (10% grade 1, 4% grade 2) and were mainly limited to the first infusion.
Moreover, first biomarker data on CD38 expression on plasma cells derived from bone marrow of all five MM patients with available second biopsies, suggested that the CD38 target molecule was preserved during MOR202 therapy comparing values at baseline and at cycle 2 day1.
“We are very pleased with the updated clinical results for MOR202 in multiple myeloma, in particular with two complete responses out of five patients treated with MOR202 plus Pom/Dex. Since we last reported data in December 2015, new and deep responses have been reported with MOR202 in combination with IMiDs. On the safety side, we were pleased to observe that MOR202 could be given to all patients in a 2-hour infusion time, with infusion-related reactions of grade 1 and 2 in only 14% of patients,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. “The dose escalation study will continue as planned, focusing on the combination treatment, in particular the upcoming cohorts of 16mg/kg MOR202 plus Pom/Dex and Len/Dex.”
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.
MOR208: Updated results confirm responses. Subgroup analysis shows target lesion shrinkage in patients with stable disease and activity of MOR208 independent of the response to a prior rituximab treatment
In addition, MorphoSys today presented updated clinical data including a subgroup analysis of a phase 2a study with the anti-CD19 antibody MOR208 in relapsed/refractory patients with various subtypes of non-Hodgkin’s lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL). All patients had received at least one prior rituximab-containing therapy.
According to the subgroup analysis data presented today, in addition to patients achieving a partial or complete response (PR, CR), a clinical benefit was also observed in other patients treated with MOR208. The majority of patients (5/6 DLBCL and 12/16 iNHL) with stable disease (SD) also had a reduction in the size of the target lesions – despite the short treatment period of 3 cycles according to protocol. This resulted in a disease control rate of 40% in DLBCL and 73% in iNHL patients. Moreover, progression-free survival (PFS) with MOR208 therapy was observed to be comparable in rituximab refractory and non-refractory NHL patients (median PFS 5.3 versus 6.6 months, HR 0.85, 95% CI 0.45-1.6, p=0.59). Thus, MOR208 has demonstrated in this trial activity independent of the response to a prior anti-CD20 therapy. Updated data for the overall trial population furthermore revealed that after 12 months the PFS rate was 40% in both DLBCL and iNHL patients. Nine patients treated with MOR208 are still in remission (7 CRs, 2 PRs), the longest responses currently ongoing for 26 months.
“We are very happy with the updated clinical trial results with MOR208,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. “We are impressed by the duration of responses of up to 26 months with MOR208 as a single-agent in heavily pre-treated patients with relapsed/refractory NHL. We were further pleased to observe a decline in the size of the tumor lesions in many in the subgroup of patients with stable disease even when treated for a short period of 3 cycles only. Overall, the updated clinical data presented at ASCO strongly support our strategy to develop MOR208 in B cell malignancies, in particular our planned combination trials in DLBCL and CLL.”
MOR208 is an anti-CD19 antibody with a proprietary modification to the Fc portion in clinical development to treat B cell malignancies. The open-label, phase 2a, multicenter study was designed to assess the activity and safety of weekly doses of 12 mg/kg MOR208 as a single agent in 92 pre-treated patients with various subtypes of relapsed/refractory NHL patients. According to the data observed, MOR208 showed a low level of infusion reactions. The overall response rate (ORR) of MOR208 reached 36% in the DLBCL subgroup and 33% in iNHL patients (both based on evaluable patients). Based on all patients with DLBCL and iNHL in the study, the ORR was 26% and 29%, respectively.
In addition, the trial design of a phase 2 study of MOR208 (COSMOS trial) was presented at the ASCO 2016 Annual Meeting. The trial is planned to evaluate MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), in patients no longer responding to or no longer tolerating Bruton’s tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib). After the discontinuation of several combination trials of idelalisib with other compounds, this planned trial is currently under review and discussions with regulatory authorities are ongoing. MorphoSys is currently exploring alternative study designs to evaluate MOR208 in a combination trial in CLL/SLL patients previously treated with a BTK inhibitor.
The posters presented at the Annual ASCO Meeting, June 6, 2016, 8:30 am CDT (2:30 pm BST, 3:30 pm CEST), can be downloaded from the Company’s website.
Abstract #8012
M. Raab et al: MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed or refractory multiple myeloma: Data from clinically relevant cohorts from a phase 1/2a study.
Abstract #7545
W. Jurczak et al: Subgroup analyses of diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma cohorts from a phase 2a study of single-agent MOR208 in patients with relapsed or refractory non-Hodgkin’s lymphoma (R-R NHL).
Abstract #TPS7572
C.-M. Wendtner et al: A phase 2 study of MOR208 plus idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor.
MorphoSys will hold on June 6, 2016 at 6:30 p.m. CDT (June 7, 2016 0:30 a.m. BST, 1:30 a.m. CEST) an Investor & Analyst Event at the 2016 ASCO Annual Meeting. KOLs will present the new clinical data for MOR208 and MOR202. A replay and the presentation will be made available at http://www.morphosys.com. Live-Webcast: http://morphosys.equisolvewebcast.com/investor-event-6-6-16
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: 58
