Klik op de vet gemaakte abstractnummers voor de abstracten
Clinical Science Symposium
Available Starting on Friday, June 4, 2021; 9:00 EDT
5509 Evaluation of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in cervical cancer: Data from phase 1 and phase 2 studies. J Strauss, FS Braiteh, E Calvo, et al
- The authors present pooled safety and efficacy data from phase I and II trials of bintrafusp alfa for 39 patients with heavily pretreated, immune checkpoint inhibitor–naive, recurrent/metastatic cervical cancer. Median treatment duration was 2.8 months (range, 0.5–19.3 months), with 2 complete responses and 9 partial responses. Median response duration was 11.7 months (range, 1.4–41.2 months), with 1 delayed partial response of 23.7 months in duration. Median OS was 13.4 months (95% CI, 5.5–not reached), and 24-month OS rate was 33.2%. Treatment-related adverse events (TRAEs) of any grade were experienced by 84.6% of patients, with 8 patients having grade 3 TRAEs and 1 patient having a grade 4 TRAE. There were no treatment-related deaths.
- Bintrafusp alfa demonstrated clinical benefit and an acceptable safety profile in this patient population.
Poster Discussion Session: Gynecologic Cancer
Available Starting on Friday, June 4, 2021; 9:00 EDT
5514 Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial. P Pautier, P Harter, C Pisano, et al
- In the phase III PAOLA-1 trial, patients with newly diagnosed FIGO stage III–IV high-grade ovarian cancer who were in response after receiving platinum-based chemotherapy plus bevacizumab (bev) were treated with bevacizumab and either olaparib (ola) or placebo (pbo). Here, the authors report on efficacy in HRD-positive patients by disease stage. Of 806 patients, 387 were HRD-positive; of these, 70% had stage III disease and 30% had stage IV disease. Median progression-free survival (PFS) for stage III patients (n = 182) was 39.3 months for those receiving ola + bev and 19.9 months for those receiving pbo + bev (HR, 0.32; 95% CI, 0.22–0.47); for stage IV patients (n = 73) it was 25.1 months and 12.8 months, respectively (HR, 0.32; 95% CI, 0.20–0.52). Median second PFS for stage III patients was not estimable (NE) for the ola + bev group (95% CI, 50.3–NE) and was 43.0 months for the pbo + bev group; for stage IV patients, it was 37.8 months and 25.6 months, respectively (HR, 0.56; 95% CI, 0.35–0.91).
- In these patients, the combination of bev + ola resulted in greater PFS and second PFS benefit than bev + pbo regardless of FIGO stage.
5517 Subgroup analysis of rucaparib versus chemotherapy as treatment for BRCA-mutated, advanced, relapsed ovarian carcinoma: Effect of platinum sensitivity in the randomized, phase 3 study ARIEL4. AM Oza, AS Lisyanskaya, AA Fedenko, et al
- For evaluation of the effect of platinum sensitivity on the efficacy of rucaparib versus chemotherapy, patients with advanced, relapsed ovarian carcinoma and a deleterious BRCA1/2 mutation were randomized 2:1 to receive either oral rucaparib 600 mg twice daily or chemotherapy and were stratified based on PFS interval (1–6 months = platinum-resistant; 6–12 months = partially platinum-sensitive; ≥12 months = fully platinum-sensitive).
- For those receiving rucaparib, the objective response rate and median progression-free survival were 23% and 6.4 months, respectively, in the platinum-resistant group; 53% and 8.0 months, respectively, in the partially platinum-sensitive group; and 64% and 12.9 months, respectively, in the fully platinum-sensitive group. For those receiving chemotherapy, the objective response rate and median progression-free survival were 27% and 5.7 months, respectively, in the platinum-resistant group; 20% and 5.5 months, respectively, in the partially platinum-sensitive group; and 57% and 9.6 months, respectively, in the fully platinum-sensitive group. The data suggest that rucaparib is a treatment option in this patient population across all subgroups of platinum sensitivity.
5518 Niraparib efficacy and safety in patients with BRCA mutated (BRCAm) ovarian cancer: Results from three phase 3 niraparib trials. AG Martin, UA Matulonis, J Korach, et al
- The authors summarize data from the PRIMA, NOVA, and NORA phase III trials on the safety and efficacy of niraparib in patients with BRCA-mutated ovarian cancer.
- Across all three trials, niraparib maintenance treatment produced significant benefit for this patient population in terms of progression-free survival. Anemia, hypertension, neutropenia, and thrombocytopenia were the most common treatment-emergent adverse events.
Poster Session: Gynecologic Cancer
Available Starting on Friday, June 4, 2021; 9:00 EDT
5551 Serum-based assay for adnexal mass risk of ovarian malignancy. D Ure, R Bullock, G Altwerger, et al
- The authors used protein biomarker data from 2688 serum specimens collected from patients with an adnexal mass to develop a novel deep-learning neural network to assess ovarian cancer risk.
- The algorithm was able to detect 91.3% of malignancies in a randomized sample set used for independent validation, compared with 65.2% for CA125, the standard-of-care biomarker test. The null hypothesis of equivalent specificity was not rejected. This algorithm could be useful for decisions concerning surgical referrals.
Oral Abstract Session: Gynecologic Cancer
Monday, June 7, 2021; 8:00 AM–11:00 AM EDT
5500 Efficacy and safety results from neopembrov study, a randomized phase II trial of neoadjuvant chemotherapy (CT) with or without pembrolizumab (P) followed by interval debulking surgery and standard systemic therapy ± P for advanced high-grade serous carcinoma (HGSC): A GINECO study. IL Ray-Coquard, AM Savoye, M-a Mouret-Reynier, et al
- The authors of this multicenter, open-label, noncomparative, randomized phase II trial sought to determine whether the addition of pembrolizumab (P) to neoadjuvant carboplatin–paclitaxel (CP) chemotherapy would increase the optimal debulking rate in patients with initially unresectable advanced ovarian, tubal, or peritoneal high-grade serous carcinoma. Complete resection was achieved for 71% of the P+CP group and 58% of the CP group. At 18 months, the PFS rate was 61% in the P+CP group (95% CI, 47–73) and 57% in the CP group (95% CI, 37–72). Postoperative adverse events, which were mainly gastrointestinal, infectious, or vascular, were experienced by 20% of the P+CP patients and 13% of the CP patients.
- The authors concluded that pembrolizumab can be safely added to treatment before interval debulking surgery in this patient population, with the primary objective of improved clinical response rate being met in the P+CP group. Further study is ongoing.
5501 Optimal treatment duration of bevacizumab (BEV) combined with carboplatin and paclitaxel in patients (pts) with primary epithelial ovarian (EOC), fallopian tube (FTC) or peritoneal cancer (PPC): A multicenter open-label randomized 2-arm phase 3 ENGOT/GCIG trial of the AGO Study Group, GINECO, and NSGO (AGO-OVAR 17/BOOST, GINECO OV118, ENGOT Ov-15, NCT01462890). J Pfisterer, F Joly, G Kristensen, et al
- The authors present the primary results from a multicenter, open-label, randomized phase III trial designed to determine the optimal duration of bevacizumab treatment in patients with FIGO stage IIB–IV ovarian, fallopian tube, or peritoneal cancer. Patients received primary cytoreductive surgery and subsequent chemotherapy (paclitaxel + carboplatin) and bevacizumab, with the bevacizumab duration being either 15 months (standard arm, n = 464) or 30 months (experimental arm, n = 463). The primary endpoint was PFS.
- Median PFS was 24.2 months in the standard arm and 26.0 months in the experimental arm. Median OS was 54.3 months in the standard arm and 60.0 in the experimental arm. The authors concluded that giving bevacizumab up to 30 months did not improve PFS or OS in these patients; therefore, 15 months of bevacizumab treatment remains the standard of care.
5503 Phase 3, randomized, single-dose, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer. JL Tanyi, HS Chon, MAl Morgan, et al
- The authors investigated the safety and efficacy of intravenous pafolacianine sodium (PS) as an adjunct to intraoperative near-infrared fluorescent (NIRF) imaging of folate receptor–positive ovarian cancer. A total of 150 patients received PS (0.025 mg/kg IV) ≥1 hour before imaging. In 33% of patients, NIRF imaging with PS revealed additional lesions that had not been planned for resection and had not been identified by normal white light and palpation (P < .001); the rate was 39.7% in patients who received interval debulking surgery. R0 resection was obtained in 62.4% of patients. No serious PS-related adverse events occurred.
- Pafolacianine sodium may be a useful addition to surgical imaging in the treatment of patients with ovarian cancer.
5504 Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-agnostic ovarian cancer: Final analysis. DM O'Malley, A Oaknin, UA Matulonis, et al
- In this phase Ib trial, 60 patients with folate receptor alpha (FRα)–positive, platinum-agnostic ovarian cancer received the combination of bevacizumab and mirvetuximab soravtansine, a FRα-binding antibody–drug conjugate. Median follow-up was 17.5 months. The overall response rate was 47%, median duration of response was 9.7 months, and median progression-free survival was 8.3 months. Treatment-related adverse events that occurred most frequently were diarrhea, fatigue, nausea, and blurred vision.
- The combination of bevacizumab and mirvetuximab soravtansine was well-tolerated and resulted in durable responses in this study. Mirvetuximab soravtansine may have a role in the treatment of patients with high-expression FRα recurrent ovarian cancer irrespective of platinum-sensitivity status.
5506 Intensive versus minimalist follow-up in patients treated for endometrial cancer: A multicentric randomized controlled trial (The TOTEM study—NCT00916708). P Zola, G Ciccone, E Piovano, et al
- This 42-center study was designed to evaluate whether an intensive versus a minimalist 5-year follow-up regimen improves OS of patients with endometrial cancer. Patients who had been surgically treated for endometrial cancer and were in complete clinical remission were stratified by center and risk of recurrence and randomized to either an intensive or a minimalist follow-up plan.
- Patient compliance was similar between the two arms, although the mean number of recorded laboratory/imaging exams was 9.7 in the intensive arm versus 2.9 in the minimalist arm. The 5-year OS was 90.6% in the intensive arm and 91.9% in the minimalist arm (P = .429). The authors concluded that intensive follow-up with more laboratory and imaging exams did not improve OS in patients with endometrial cancer and should be discouraged.
5507 Victoria: A multicentric, randomized, open-label, phase I/II of mTOR inhibitor (VISTUSERTIB) combined with anastrozole in patients with hormone receptor-positive advanced/metastatic endometrial cancer—A CLIPP program INCA in collaboration with GINECO group. P-E Heudel, J-S Frenel, C Dalban, et al
- In this study, 73 patients with recurrent estrogen- or progesterone-positive advanced/metastatic endometrial carcinoma were randomized to receive either the combination of vistusertib and anastrozole or anastrozole alone. The overall response rate was 24.5% in the combination arm and 17.4% in the anastrozole-alone arm. The median PFS was 5.2 months for patients receiving the combination and 1.9 months for those receiving anastrozole alone. The most common drug-related adverse events were diarrhea, fatigue, lymphopenia, and hyperglycemia.
- The combination of vistusertib and anastrozole produced clinical benefit in these patients, with tolerable toxicity.
5508 Pertuzumab plus trastuzumab (P+T) in patients (Pts) with uterine cancer (UC) with ERBB2 or ERBB3 amplification, overexpression or mutation: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study. HM Ali-Ahmad, M Roth, PK Mangat, et al
- The authors report results for a cohort of 28 patients with heavily pretreated uterine cancer with ERBB2 or ERBB3 amplification, overexpression, or mutation treated with the combination of pertuzumab and trastuzumab.
- The disease-control rate (partial response, complete response, or stable disease at 16+ weeks) was 37%, the objective response rate was 7.1%, the median progression-free survival was 28.1 weeks, and 1-year overall survival was 53.4%. The combination of pertuzumab and trastuzumab led to antitumor activity in this patient population. Further study is warranted.
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