KEY TAKEAWAYS
- This Phase II clinical trial (NCT02500407) delved into the efficacity and safety of Mosunetuzumab as a monotherapy in cases with regressed refractory follicular carcinoma after entering ≥ 2 previous treatments.
- A Complete Response rate of 60.0 (95% CI 49.1 –70.2) was observed, with an unestimated standard DOR and DOCR.
- Post-hoc analysis showed an increase in RR, PFS, DOR, DOCR, and Time to Next Therapy or Death compared to the former remedy.
- CRS occurrences were grade 1/2 and passed substantially during the first cycle, with no significant correlation between CRS and tumor response.
Mosunetuzumab (Mosun) is a CD20xCD3 T-cell engaging bispecific monoclonal antibody(Bi-mAb) that redirects T cells to target nasty B cells. Mosun was approved by the European Medicines Agency( EMA) in 2022 for the treatment of cases( pts) with regressed refractory( R/ R) follicular carcinoma( FL). It’s a fixed-duration remedy that can be administered on an inpatient base. In a Phase II study( NCT02500407), Mosun demonstrated a high rate of complete response( CR) with a manageable safety profile in pts with R/ R FL who had formerly entered at least two previous curatives( Budde et al. Lancet Oncol 2022). This report provides streamlined data for this cohort after a standard follow-up of 27 months.
The study included pts with FL grade( gr) 1 – 3a who had formerly entered a minimum of two previous curatives, including an anti-CD20 antibody and an alkylator. Mosun was administered in 21-day cycles with step-up dosing in Cycle( C) 1( Day( D) 1, 1 mg; C1D8, 2 mg; C1D15/ C2D1, 60 mg; C3D1 and onwards, 30 mg). The primary endpoint was the CR rate determined by an Independent Review Committee. Of the 90 pts enrolled in the study, the median age was 60 times( range 29 – 90), and 77 had stage III/ IV complaints. The median number of previous remedy lines was three( range 2 – 10); 53 pts were double refractory to cosign anti-CD20 remedy and alkylator remedy, and 52 pts had complaint progression within 24 months of starting their first-line treatment. As of May 20, 2022, the median time in the study was 26.7 months( range2.0 –36.2).
Of the 90 pts, 54(60%) had completed original treatment, 36(40%) had discontinued original treatment( 28 due to progressive complaint), 2(2%) were witnessing retreatment, 72( 80) were in follow- up, and 16(18%) had discontinued the study. The INV-assessed objective response rate (ORR) and CR rate in the study population of 90 pts were 77.8 (95% CI 67.8 –85.9) and 60.0 (95% CI 49.1 –70.2), independently. The median DOR and DOCR weren’t reached;79.5 of complete askers remained absolved for at least 24 months, grounded on Kaplan- Meier estimates. The median PFS per INV assessment was NR; the 24-month PFS was 51.4 ( 95%CI 39.4 –63.3). Overall, response rates, PFS, DOR, DOCR, and time to posterior remedy or death were each bettered with Mosun compared with the former treatment( Table; Figure).
The rate of AEs leading to termination was low (4.4), and no treatment-related gr 5 AEs were observed. CRS events (44.4 of pts) were substantially confined to C1 (84.5 of events), and 97.2 were gr1/2 inflexible; all CRS events were resolved. No correlation was observed between the circumstance of CRS and tumor response. ORR was77.5 and78.0, independently, in pts with or without CRS events. In conclusion, the streamlined data from this study, with a standard follow-up of 27 months, shows that Mosun provides durable responses in pts with R/ R FL.
Source:https://ash.confex.com/ash/2022/webprogram/Paper157691.html
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02500407/
Bartlett, N., Sehn L, Matasar M, Schuster S, Assoulines S, Giris P, Kuruvilla J, Canales M, Dietrich S, Fay K, Ku M, Nastoupil L, Wei M, Yin S, To I, Huang H, Min J, Penuel E, and Budde E (2022). Mosunetuzumab Monotherapy Demonstrates Durable Efficacy with a Manageable Safety Profile in Patients with Relapsed/Refractory Follicular Lymphoma Who Received ≥2 Prior Therapies: Updated Results from a Pivotal Phase II Study. [online] ash.confex.com. Available at: https://ash.confex.com/ash/2022/webprogram/Paper157691.html [Accessed 20 Feb. 2023].
