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A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma (InMIND)

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma (InMIND)

654

A total of 654 participants were enrolled and randomized, including 548 participants with FL and 106 participants with MZL. In the FL FAS, the median age was 64.0 years (range: 36-88 years) and 64.0 years (range: 31 85 years) in the tafasitamab+R2 group and placebo+R2 group, respectively. A similar proportion of male (54.9% and 54.2%) and female (45.1% and 45.8%) participants were enrolled. In the MZL FAS, the median age was 69.0 years (range: 30-86 years) and 69.0 years (range: 29-87 years) in the tafasitamab+R2 group and placebo+R2 group, respectively. A similar proportion of male (49.1% and 50.9%) and female (50.9% and 49.1%) participants were enrolled.

Fifty-one participants (18.7%) in the tafasitamab+R2 group and 42 participants (15.3%) in the placebo+R2 group were receiving ongoing treatment. A total of 222 participants (81.3%) and 231 participants (84.0%) had discontinued treatment, respectively.

In the Overall Safety Population, TEAEs were reported for 99.4% of participants in the tafasitamab+R2 group and for 99.1% of participants in the placebo+R2 group. Grade 3 or 4 TEAEs were reported for 72.8% of participants in the tafasitamab+R2 group and for 70.5% of participants in the placebo+R2 group.

Primary Outcome measures The primary endpoint of the study was met, demonstrating that addition of tafasitamab to R2 provides a statistically significant and clinically meaningful improvement in PFS in the FL FAS, with an estimated HR of 0.434 (95% CI: 0.324, 0.580) and a p-value of < 0.0001. Secondary Outcome Measures The significant improvement in PFS in the Overall FAS was demonstrated, with an estimated HR of 0.500 (95% CI: 0.383, 0.653) and a p-value of < 0.0001. The statistically significant improvement in PET-CR rate in the FL FDG-Avid Set was demonstrated, with an OR of 1.5 (95% CI: 1.04, 2.13) and a p-value of 0.0286.

Tafasitamab in combination with R2 demonstrated a statistically significant and clinically meaningful improvement in PFS in participants with R/R FL compared with placebo + R2. Tafasitamab in combination with R2 represents a new therapeutic option for patients with R/R FL, demonstrating a positive benefit/risk ratio with significant clinical benefit and a manageable safety profile.

Yes

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

https://jrct.mhlw.go.jp/latest-detail/jRCT2021210065

Suzukawa Kazumi

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku

jpmedinfo@incyte.com

Medical Information Center

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku

+81-120-094-139

jpmedinfo@incyte.com

Complete

Jan. 14, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- Willingness to avoid pregnancy or fathering children
- In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
- Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
- Documented relapsed, refractory, or PD after treatment with systemic therapy
- ECOG performance status of 0 to 2

- Women who are pregnant or breastfeeding.
- Any histology other than FL and MZL or clinical evidence of transformed lymphoma
- Prior non-hematologic malignancy
- Congestive heart failure
- HCV positivity, chronic HBV infection or history of HIV infection
- Active systemic infection
- CNS lymphoma involvement
- Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
- Prior use of lenalidomide in combination with rituximab

Both

Follicular Lymphoma, Marginal Zone Lymphoma

Arm A : tafasitamab + rituximab + lenalidomide
Tafasitamab (INCMOR00208, MOR00208) will be administered IV for 12 cycles.
Rituximab will be administered IV on cycles 1 - 5.
Lenalidomide will be administered PO for 12 cycles.

Arm B : placebo + rituximab + lenalidomide
Placebo will be administered IV for 12 cycles.
Rituximab will be administered IV on cycles 1 - 5.
Lenalidomide will be administered PO for 12 cycles.

1. FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria
2. FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria

1. Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria
2. Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria
3. FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria
4. FL Population: Overall Survival
5. FL Population: Kaplan-Meier Estimates of Overall Survival
6. FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
7. FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment
8. Overall Population: MRD-negativity Rate (at Threshold of 10^-5) at End of Treatment
9. FL Population: Overall Response Rate by Investigator Assessment
10. Overall Population: Overall Response Rate by Investigator Assessment
11. FL Population: Duration of Response by Investigator Assessment
12. FL Population: Kaplan-Meier Estimates of DOR by Investigator Assessment
13. Overall Population: DOR by Investigator Assessment
14. Overall Population: Kaplan-Meier Estimates of DOR by Investigator Assessment
15. Overall Population: Overall Survival
16. Overall Population: Kaplan-Meier Estimates of Overall Survival
17. FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria
18. FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria
19. Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria
20. Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria
21. FL Population: Overall Response Rate by IRC Review
22. Overall Population: Overall Response Rate by IRC Review
23. FL Population: DOR by IRC Review
24. FL Population: Kaplan-Meier Estimates of DOR by IRC Review
25. Overall Population: DOR by IRC Review
26. Overall Population: Kaplan-Meier Estimates of DOR by IRC Review
27. FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
28. Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
29. FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
30. Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
31. FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
32. Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
33. FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
34. Overall Population: FACT-Lym Scores at Baseline and End of Treatment

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Dec. 07, 2021

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