7517 Background: Gain or amplification of 1q21 (1q21+, ≥3 copies) is a chromosomal abnormality often detected in MM that can negatively affect prognosis by its involvement in resistance to therapy and MM progression. Results from the global, randomized Phase 3 IMROZ study (NCT03319667) demonstrated significant progression-free survival (PFS) benefit with Isa-VRd followed by Isa-Rd compared with VRd followed by Rd, along with deep and sustained responses, in transplant-ineligible patients (pts) with NDMM. To evaluate efficacy of combination treatment with Isa-VRd/Isa-Rd vs VRd/Rd in NDMM pts with 1q21+ status, we analyzed clinical outcomes (PFS, overall response, minimal residual disease negativity [MRD–]) for 1q21+ pts in the IMROZ study. Methods: In IMROZ, 446 pts were randomized 3:2 to receive Isa-VRd (n=265) in the initiation phase followed by maintenance with Isa-Rd vs VRd (n=181) followed by Rd. 1q21+ status was assessed by FISH (30% cutoff) and prespecified as ≥3 copies (gain=3, amplification >3). Isolated 1q21+ was defined as presence of 1q21+ and absence of high-risk chromosomal abnormalities [HRCAs; del(17p), t(4;14), t(14;16)]. MRD data by NGS were reported at 10 -5 sensitivity threshold. Results: Overall, 35.9% and 38.7% of pts had 1q21+ status in the Isa-VRd and VRd arms, respectively (23.8% and 26.0% with gain(1q21), 12.1% and 12.7% with amp(1q21); 7.2% and 8.3% also had ≥1 HRCA). Treatment with Isa-VRd significantly prolonged PFS vs VRd in 1q21+ pts (with or without HRCA) and in pts with isolated 1q21+ (see Table) and led to higher rates of complete response (CR) and MRD–. A substantially greater proportion of pts with 1q21+ or isolated 1q21+ achieved MRD– CR and sustained MRD– for ≥12 months with Isa-VRd than with VRd. Data for gain(1q21) and amp(1q21) will be presented. Conclusions: Results from our analysis of outcomes in 1q21+ pts in the IMROZ trial demonstrate consistent PFS benefit with Isa-VRd vs VRd, as reported in the overall study population. Benefit was observed regardless of 1q21+ or isolated 1q21+ status.These findings are in line with similar analyses done with Isa-pomalidomide-dexamethasone and Isa-carfilzomib-dexamethasone in Phase 3 studies. Clinical trial information: NCT03319667 . 1q21+ Isolated 1q21+ a Standard risk a Isa-VRd VRd Isa-VRd VRd Isa-VRd VRd n (%) 95 (35.9) 70 (38.7) 75 (28.3) 55 (30.9) 207 (78.1) 140 (77.4) mPFS, mo(95% CI) NR(NR–NR) 39.13(22.93–48.95) NR(NR–NR) 43.01(20.60–59.70) NR(NR–NR) 53.91(43.01–NR) PFS HR (95% CI) 0.407 (0.253–0.653) p =0.0002 0.369 (0.213–0.642) p =0.0004 0.517 (0.363–0.737) p =0.0003 ORR % 95.8 85.7 96.0 81.8 97.5 100 ≥CR % 76.9 60.0 78.7 52.7 72.5 79.4 MRD– % 63.2 41.4 65.3 40.0 58.9 40.7 MRD– CR % 62.1 38.6 64.0 36.4 55.6 37.9 Sustained MRD– ≥12 mo % 51.6 22.9 50.7 23.6 45.4 22.9 a Absence of del(17p), t(4;14) and t(14;16). NR, not reached.
Background. A Russian phase IV observational study was initiated to evaluate the efficacy and safety of lenvatinib with pembrolizumab (Len-Pembro) in patients with advanced renal cell carcinoma (RCC) receiving therapy in real-world practice. This article is based on the results of the third analysis conducted with a median follow-up of 23.1 months and reflects data on the efficacy and safety of Len-Pembro in Russian patients. Aim. To evaluate the real-world efficacy and safety of Len-Pembro in patients with advanced RCC with a median follow-up increased to 23.1 months. The primary outcome of the study was progression-free survival (PFS), the secondary outcomes included overall survival (OS), progression-free survival on next-line therapy (PFS2), objective response rate (ORR), duration of response, as well as safety. Materials and methods. The study included data from 165 patients with verified advanced RCC who received Len-Pembro at 36 centers in the Russian Federation from February 05, 2018 to July 30, 2025. The median age was 60 (20–76) years, and 70.3% of the participants were male. Most patients (74.6%) presented with Karnofsky performance score of ≥80%, metachronous metastases (50.9%) of clear cell RCC (93.3%) in 1 organ (75.2%), and had not received any anticancer treatment (91.0%). The IMDC favorable prognosis group included 40 (24.2%), intermediate – 92 (55.8%), and unfavorable prognosis – 33 (20.0%) patients. The median follow-up reached 23.1 (0.5–72.9) months. A total of 110 (66.7%) patients completed Len-Pembro therapy, and 51 (30.9%) patients received next-line treatment. Results. Median PFS reached 25.8 (95% confidence interval – CI 17.0–34.5) months, 23-month PFS – 52.6%; median OS was 39.9 (95% CI 26.9–52.8) months, 23-month OS – 73.1%; median PFS2 was 33.2 (95% CI 23.4–41.1) months, 23-month PFS2 – 66.9%. The ORR was 49.1%, including 3.0% of complete responses, and the disease control rate was 89.1%. The median duration of response reached 29.7 (95% CI 24.9–34.6) months. The incidence of any adverse events (AEs) was 78.8%, severe AEs occurred in 29.1%, fatal AES – in 1.2%, immune-related AEs – 17.0%, severe immune-related AEs – 6.7%. Conclusion. In real-world practice, with increased follow-up duration, the values of PFS, OS, and PFS2 were comparable to those obtained in the registrational study, with a lower ORR and a satisfactory safety profile of the combination of Len-Pembro in advanced RCC.
The aim of the study was to evaluate the effectiveness of endoscopic retrograde cholangiopancreatography after short-loop Billrot II surgeries. Results. An analysis of 11 cases of 22 cases of endoscopic retrograde cholangiopancreatography (ERCP) after short-loop Billrot II surgeries was performed. Distal malignant strictures of the bile ducts were an indication for surgery in 6 cases, gallstones in 16. The success rate of choledochal catheterization was 100%, and the success rate of surgery was 95%. In one case, it was not possible to install a plastic stent with a dense stricture of the bile duct formed by a tumor of the pancreatic head. Stone removal using traditional baskets was effective in 100% of cases. Successful installation of plastic stents was performed in 12 cases (strictures - 4, complicated bile duct stones - 8). Conclusion. Endoscopic interventions in the pancreatobiliary zone after gastric resection with the formation of a Billrot II anastomosis are technically difficult and must be performed by an experienced endoscopist. Special technical devices and tools have been introduced to facilitate such operations. Endoscopes with end optics have some advantages in positioning, cannulation, sphincterotomy, and calculus extraction, but there are some limitations in stenting capabilities compared to traditional duodenoscopes, such as maximum stent diameter and pressure force.
A clinical case of the use of ultrasound navigation in the installation of an unloading percutaneous endoscopic gastrostomy for the purpose of decompression of the stomach in patients with impaired gastric evacuation function in the presence of a previously formed gastric stoma is presented.
7515 Background: In DREAMM-8 (NCT04484623), BPd demonstrated a statistically significant, clinically meaningful benefit to progression-free survival (PFS) vs PVd in pts with RRMM who received ≥1 prior line of treatment including lenalidomide. MRD neg has been shown to be a predictor of PFS and overall survival (OS) in MM. We assessed efficacy outcomes by MRD status. Methods: Ptswere randomized (1:1) to BPd or PVd. The primary endpoint was independent review committee (IRC)–assessed PFS; OS, duration of response, and MRD status determined by next-generation sequencing with 10 −5 sensitivity threshold was assessed in pts with complete response or better (≥CR) every 6 mo until progressive disease. Post hoc subgroup analyses of PFS and OS were conducted based on IRC-assessed response (≥CR or ≥VGPR) and MRD-neg status using Kaplan-Meier method; CIs were estimated using Brookmeyer-Crowley method. Results: 302 pts were randomized to BPd (n=155) or PVd (n=147). As previously reported (median follow-up, 21.8 mo), more pts with BPd had CR-based MRD neg vs PVd (37/155 [24%] vs 7/147 [5%]). A similar trend was seen in pts with ≥VGPR; 50/155 pts (32%) had VGPR-based MRD neg with BPd vs 8/147 (5%) with PVd. In the DREAMM-8 trial, MRD neg was associated with improved efficacy outcomes (Table). Pts with CR-based MRD neg had a lower risk of disease progression or death compared with pts without MRD neg (PFS HR, 0.14; 95% CI, 0.06-0.32; Table); median was NR overall and in each treatment arm (HR [BPd vs PVd], 0.90; 95% CI, 0.10-7.76). MRD neg pts had a lower risk of death (OS HR, 0.18; 95% CI, 0.07-0.49). In all pts who did not have CR-based MRD neg, pooled median PFS was 14.0 mo (95% CI, 11.1-18.6 mo; BPd, 19.6 mo; PVd, 10.2 mo; HR [BPd vs PVd], 0.67; 95% CI, 0.47-0.94), and the pooled 18-mo PFS rate was 46% (95% CI, 39%-52%; BPd, 52%; PVd, 39%). Median OS was NR overall, 33.0 mo (95% CI, 23.7-NR) with BPd and NR with PVd; 18-mo OS rate was 69% (95% CI, 63%-75%; BPd, 72%; PVd, 67%). Conclusions: Consistent with previous reports, MRD neg was associated with a robust benefit in PFS and OS, highlighting the significance of a greater response depth. Pts with BPd achieved a 5-fold improvement in CR-based MRD neg vs PVd (24% vs 5%). Pts who did not achieve CR-based MRD neg had a clinically meaningful benefit in PFS with BPd vs PVd. Clinical trial information: NCT04484623 . MRD neg Non-MRD neg MRD status (≥CR), n Pooled (44) BPd (37) PVd (7) Pooled (258) BPd (118) PVd (140) Median PFS (95% CI), mo NR (NR-NR) NR (NR-NR) NR (NR-NR) 14.0 (11.1-18.6) 19.6 (13.5-NR) 10.2 (8.4-17.1) 18-mo PFS rate (95% CI), % 93 (79-98) 91 (75-97) 100 (100-100) 46 (39-52) 52 (42-62) 39 (30-48) 18-mo OS rate (95% CI), % 93 (80-98) 92 (76-97) 100 (100-100) 69 (63-75) 72 (62-79) 67 (59-74)
