Start Your Search
MA05 - Update on Clinical Trials and Treatments (ID 123)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Mesothelioma
- Presentations: 1
- Now Available
- Moderators:Seiki Hasegawa, Enrico Ruffini, Angel Artal
- Coordinates: 9/08/2019, 13:30 - 15:00, Melbourne (1991)
MA05.07 - Efficacy and Safety of Re-Treatment with Tremelimumab and Durvalumab Within the NIBIT-MESO-1 Study (Now Available) (ID 1867)
13:30 - 15:00 | Author(s): Giovanni Amato
Targeting immune-checkpoint inhibitors (ICI) had proven effective in a variety of tumor types. However, primary and secondary resistance to treatment is emerging as a major limitation of ICI therapy, and scattered information is available on the therapeutic efficacy of re-treatment in ICI-resistant subjects. Here we investigated the efficacy and safety of re-treatment with tremelimumab and durvalumab in malignant mesothelioma (MM) patients who developed resistance to these agents in the phase II NIBIT-MESO-1 study (Calabrò L et al, Lancet Resp Med 2018).Method
Patients eligible for re-treatment per the NIBIT-MESO-1 protocol were those who completed 4 dosing cycles of tremelimumab combined with durvalumab, and achieved partial response (PR) or stable disease (SD), followed by progressive disease (PD) during the maintenance with durvalumab or the follow-up phase. Subjects who met the re-treatment criteria received tremelimumab (1 mg/Kg, i.v.) and durvalumab (20 mg/Kg, i.v.) every 4 weeks (Q4W) for 4 doses (re-induction phase), followed by durvalumab (20 mg/Kg, i.v.) Q4W for additional 9 doses (maintenance phase). Objective response rate (ORR), disease control rate (DCR), per immune-related (ir)-modified RECIST criteria, overall survival (OS), and safety were evaluated. Adverse events (AEs) were recorded according to CTC v4.0.Result
Seventeen (42.5%) of the 40 MM patients enrolled in the NIBIT-MESO-1 study met the criteria for re-treatment and received therapy. Among them 8 (47%) completed the re-induction phase, 7 (41.2.%) went on maintenance phase, and 1 (5%) entered the follow-up phase. As of April 1st 2019, 16/17 patients were discontinued during re-treatment because of PD, and 7 received additional lines of therapy. Seven out of the 17 (41.2%) re-treated subjects had an irSD, while no ir-ORR were observed. At a median follow-up of 35.8 months, median OS of re-treated patients was significantly (p=0.005) higher (25.6 months, 95% CI: 6.1-45.1) as compared to the 23 subjects who were not re-treated (9.9 months, 95% CI: 7.7-12.1). Grade 1-2 irAEs occurred in 6/17 (35%) re-treated patients, were most frequently dermatological and reversible per protocol guideline; no grade 3-4 irAEs were observed.Conclusion
Re-treatment with tremelimumab and durvalumab of MM patients who developed resistance to therapy in the course of the NIBIT-MESO-1 study is clinically effective and safe in a sizeable proportion of re-treated subjects.
Clinical trial infomation: NCT02588131
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.