DLBCL and FL Identified as Particularly Promising Indications
MARTINSRIED / MUNICH, Germany I December 8, 2014 I MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced promising clinical data on its proprietary drug candidate MOR208 from a phase 2a study in 89 patients with four different subtypes of relapsed or refractory Non-Hodgkin’s Lymphoma (NHL). MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion that is being developed to treat B-cell malignancies. The preliminary clinical data, which were presented today at the 56th Annual Meeting of the American Society of Hematology (ASH), show that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent efficacy.
“The data we have generated so far in NHL, which included four complete responses in total, provide strong support for the MOR208 program. The signal searching approach we applied to this study has identified in particular diffuse large B-cell lymphoma and follicular lymphoma as valuable development options for this compound. It is worth noting, that MOR208 is a naked antibody that was used as monotherapy in this trial. The very encouraging single-agent activity and solid safety profile bode well for future development,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
The open-label, phase 2a, multicenter study was designed to assess the efficacy and safety of single-agent MOR208 in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL), who had received at least one prior rituximab-containing therapy. Patients were initially treated with a total of eight weekly doses of MOR208. Those with at least stable disease stayed on MOR208 treatment for an additional four weeks. After completion of these twelve weekly doses of treatment, responding patients (complete or partial response) received maintenance therapy until progression.
The study used a two-stage design. In stage 1, approximately ten patients were enrolled in each of the four NHL subtypes. The DLBCL and FL cohorts which saw two or more responses (complete or partial response) in stage 1 were expanded in stage 2. The data presented today at ASH summarizes efficacy and safety results for 89 patients enrolled as of 17 November 2014 in stages 1 and 2 of this trial.
Investigator assessed response in the NHL subtype specific cohorts
| Efficacy outcome |
NHL subtypes (patients per cohort) |
|
DLBCL
(35) |
FL
(31) |
MCL
(12) |
iNHL
(11) |
Overall
(89) |
| Complete responses |
2 |
1 |
0 |
1 |
4 |
| Partial responses |
7 |
6 |
0 |
1 |
14 |
| Stable disease |
5 |
14 |
6 |
3 |
28 |
| Progressive disease |
11 |
4 |
5 |
3 |
23 |
| Not evaluable |
10 |
11 |
1 |
1 |
23 |
| ORR* per cohort |
26%
(9 pts) |
23%
(7 pts) |
0%
(0 pts) |
18%
(2 pts) |
20%
(18 pts) |
*Overall Response Rate (ORR) = Number of complete responses + partial responses versus total
DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; iNHL, indolent non-Hodgkin’s lymphoma; MCL, mantle cell lymphoma; NHL, non-Hodgkin’s lymphoma; pts, patients
MOR208 was granted orphan drug designation in DLBCL (US) and CLL (US and Europe) in 2014. Additionally, the FDA has granted fast track designation for the treatment of DLBCL.
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 90 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: 222
DLBCL and FL Identified as Particularly Promising Indications
MARTINSRIED / MUNICH, Germany I December 8, 2014 I MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced promising clinical data on its proprietary drug candidate MOR208 from a phase 2a study in 89 patients with four different subtypes of relapsed or refractory Non-Hodgkin’s Lymphoma (NHL). MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion that is being developed to treat B-cell malignancies. The preliminary clinical data, which were presented today at the 56th Annual Meeting of the American Society of Hematology (ASH), show that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent efficacy.
“The data we have generated so far in NHL, which included four complete responses in total, provide strong support for the MOR208 program. The signal searching approach we applied to this study has identified in particular diffuse large B-cell lymphoma and follicular lymphoma as valuable development options for this compound. It is worth noting, that MOR208 is a naked antibody that was used as monotherapy in this trial. The very encouraging single-agent activity and solid safety profile bode well for future development,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
The open-label, phase 2a, multicenter study was designed to assess the efficacy and safety of single-agent MOR208 in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL), who had received at least one prior rituximab-containing therapy. Patients were initially treated with a total of eight weekly doses of MOR208. Those with at least stable disease stayed on MOR208 treatment for an additional four weeks. After completion of these twelve weekly doses of treatment, responding patients (complete or partial response) received maintenance therapy until progression.
The study used a two-stage design. In stage 1, approximately ten patients were enrolled in each of the four NHL subtypes. The DLBCL and FL cohorts which saw two or more responses (complete or partial response) in stage 1 were expanded in stage 2. The data presented today at ASH summarizes efficacy and safety results for 89 patients enrolled as of 17 November 2014 in stages 1 and 2 of this trial.
Investigator assessed response in the NHL subtype specific cohorts
| Efficacy outcome |
NHL subtypes (patients per cohort) |
|
DLBCL
(35) |
FL
(31) |
MCL
(12) |
iNHL
(11) |
Overall
(89) |
| Complete responses |
2 |
1 |
0 |
1 |
4 |
| Partial responses |
7 |
6 |
0 |
1 |
14 |
| Stable disease |
5 |
14 |
6 |
3 |
28 |
| Progressive disease |
11 |
4 |
5 |
3 |
23 |
| Not evaluable |
10 |
11 |
1 |
1 |
23 |
| ORR* per cohort |
26%
(9 pts) |
23%
(7 pts) |
0%
(0 pts) |
18%
(2 pts) |
20%
(18 pts) |
*Overall Response Rate (ORR) = Number of complete responses + partial responses versus total
DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; iNHL, indolent non-Hodgkin’s lymphoma; MCL, mantle cell lymphoma; NHL, non-Hodgkin’s lymphoma; pts, patients
MOR208 was granted orphan drug designation in DLBCL (US) and CLL (US and Europe) in 2014. Additionally, the FDA has granted fast track designation for the treatment of DLBCL.
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 90 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: 222
