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TJ202 / MOR202 granted Investigational New Drug (IND) application in China
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The National Medical Products Administration (NMPA) of China have granted TJ202 / MOR202 investigational new drug (IND) clearance, allowing the pharmaceutical companies responsible for its development to expand the ongoing phase II and III clinical trials.1
TJ202 / MOR202 is an anti-CD38 monoclonal antibody under investigation for the treatment of multiple myeloma (MM). The suggested mode of action (MoA) indicates that TJ202 / MOR202 recruits cells of the immune system to kill tumor cells via antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The MoA does not involve complement dependent cytotoxicity (CDC) as it does not trigger complement activation.1
TJ202 / MOR202 in Asia
There are two ongoing clinical trials in Taiwan (detailed below) which will now be expanded to mainland China following the approval from the NMPA.1
- NCT03860038, phase II study to evaluate the efficacy and safety of:1
- TJ202 / MOR202 + dexamethasone (dex)
- As third-line treatment of patients with relapsed/refractory MM (RRMM)
- Primary endpoint: overall response rate (ORR)
- NCT03952091, phase III study to evaluate the efficacy and safety of:1,2
- TJ202 / MOR202 + len + dex versus len + dex alone
- Randomized, open-label, parallel-controlled, multicenter study
- Patients with RRMM who have received ≥ one prior line of treatment
- Primary endpoint: progression-free survival (PFS)
TJ202 / MOR202 in Europe3
In Europe, TJ202 / MOR202 has also been investigated in clinical trials. During the 23rd Congress of the European Hematology Association (EHA), Marc S. Raab presented results of a phase I/IIa clinical trial (NCT01421186) investigating the safety and efficacy of TJ202 / MOR202 in a dose escalation (3+ 3) design. The study recruited 56 patients with RRMM and assigned them to one of three combination treatment arms (Table 1).3
Table 1. Results of phase I/IIa study of TJ202 / MOR202 in combination treatments3
| CR, complete response; dex, dexamethasone; NR, Not reached; ORR, overall response rate; PFS, progression free survival; TEAE, treatment emergent adverse events |
|||
|
Treatment arm |
TJ202 / MOR202 + dex |
TJ202 / MOR202 + dex + pomalidomide |
TJ202 / MOR202 + dex + len |
|---|---|---|---|
|
n |
18 |
21 |
17 |
|
Median prior lines of therapy |
3 |
3 |
2 |
|
ORR, % |
28 |
48 |
65 |
|
CR, % |
0 |
10 |
12 |
|
PFS, months |
8.4 |
17.5 |
NR |
|
Most common hematological TEAEs grade III or higher, % |
|||
|
Leukopenia |
11 |
57 |
47 |
|
Lymphopenia |
39 |
48 |
59 |
|
22 |
76 |
53 |
|
|
Most common non-hematological TEAEs grade III or higher, % |
|||
|
Hypertension |
11 |
19 |
12 |
|
Pneumonia |
6 |
24 |
|
In this study, the authors concluded TJ202 / MOR202 was well-tolerated with a low incidence of infusion-related reactions (11%, all grade II or below) and low infusion time.3
- I-Mab Biopharma And MorphoSys Announce IND Clearance To Initiate Clinical Trials Of TJ202 / MOR202 For The Treatment Of Multiple Myeloma In Mainland China. https://myelomabeacon.org/pr/2019/10/14/tj202-mor202-in-clearance-mainland-china-trial-expansion/ [Accessed 2019 Oct 16]
- I-Mab Biopharma And MorphoSys Announce First Patient Dosed In Phase 3 Clinical Study Of TJ202/MOR202 In Multiple Myeloma. https://myelomabeacon.org/pr/2019/04/30/first-patient-dosed-phase-3-clinical-trial-tj202-mor202/ [Accessed 2019 Oct 16]
- Raab MS. et al., MOR202 with low-dose dexamethasone (dex) or pomalidomide/dex or lenalidomide/dex in relapsed or refractory multiple myeloma (RRMM): a phase I/IIa, multicenter, dose-escalation study. 23rd Congress of the European Hematology Association; 2018 June 14–17; Stockholm, SE. Abstract #S488
Expert Opinion
“MOR 202 is an anti-CD38 antibody that was specifically designed not to trigger complement activation in order to avoid infusion reactions (IR). Within this trial, we show that an infusion as short as 30 min is feasible and the IR rate is very low. Moreover, when given in combination with lenalidomide or pomalidomide, high response rates and long-lasting remissions could be achieved. The median progression-free survival of 17.5 months achieved using MOR202 plus pomalidomide in patients that are refractory to lenalidomide is unprecedented, and therefore, strongly warrants confirmation in larger clinical trials.”
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