- Su Pin Choo (Singapore, Singapore)
- Kohei Shitara (Kashiwa, Chiba, Japan)
LBA2 - Sintilimab plus bevacizumab biosimilar vs sorafenib as first-line treatment for advanced hepatocellular carcinoma (ORIENT-32)2 (ID 523)
- Zhenggang Ren (Shanghai, China)
Abstract
Background
ORIENT-32 is a randomized, open-label, multi-center phase II/III study to evaluate the efficacy and safety of sintilimab (anti-PD-1 antibody) plus a bevacizumab biosimilar (anti-VEGF antibody), versus sorafenib as first-line treatment for advanced hepatocellular carcinoma (HCC). The phase II part has demonstrated an acceptable safety of this combination. Here we report the result of phase III part (NCT03794440).
Methods
Patients (pts) with unresectable or metastatic, systemic treatment naive HCC were enrolled and randomized (2:1) to receive sintilimab (200 mg IV Q3W) plus bevacizumab biosimilar (15 mg/kg IV Q3W) (SinBev arm) or sorafenib (400 mg orally, BID) (Sor arm). Stratification factors were macrovascular invasion and/or extrahepatic metastasis (presence vs absence), baseline alpha fetoprotein level (< 400 vs ≥400 ng/mL) and ECOG PS (0 vs 1). The primary endpoints were OS and PFS by independent radiographic review committee (IRRC) per RECIST 1.1.
Results
As data cutoff date (Aug 15, 2020), 571 pts were enrolled to SinBev arm (n=380) and Sor arm (n=191). The baseline characteristics were well balanced between two arms, with most pts had hepatitis B infection (94.2%) and 4.2% of pts with Child-Pugh B. With a median follow-up of 10.0 m, median OS was significantly longer in SinBev arm than that in Sor arm (NE vs. 10.4 m, HR 0.57, 95%CI: 0.43-0.75, P<0.0001). Median PFS was significantly improved in SinBev arm as compared with Sor arm (4.5 m vs. 2.8 m, HR 0.57, 95%CI: 0.46-0.70, P<0.0001). The superior OS and PFS benefits with SinVev over Sor were generally consistent across all relevant subgroups. Among pts with evaluable tumor assessment at baseline, the confirmed ORR by IRRC per RECIST 1.1 was 20.3% (74/364, 95%CI: 16.3%-24.8%) in SinBev arm and 4.1% (7/172, 95%CI: 1.7%-8.2%) in Sor arm. Of pts receiving at least one drug dose, the incidences of treatment related adverse events were 88.7% in SinBev arm (n=380) and 93.5% in Sor arm (n=185). Grade 3-4 TRAEs occurred in 33.7% and 35.7% of pts, respectively.
Conclusions
Sintilimab plus bevacizumab biosimilar as first-line treatment was associated with significantly improved clinical benefits than sorafenib in pts with advanced HCC.
Clinical trial identification
NCT03794440.
Legal entity responsible for the study
The authors.
Funding
Innovent Biologics, Inc.
Disclosure
All authors have declared no conflicts of interest.
114O - Assessment of robotic versus laparoscopic distal gastrectomy for gastric cancer: A randomized controlled trial (ID 469)
- Jun Lu (Fuzhou, China)
Abstract
Background
Despite the increasing use of robotic distal gastrectomy (RDG) in patients with gastric cancer (GC), its safety and efficacy compared to those of laparoscopic distal gastrectomy (LDG) have not been elucidated in a randomized controlled trial (RCT). We aimed to evaluate the short-term outcomes of patients with GC who received RDG or LDG.
Methods
Three hundred patients with cT1-4a and N0/+ between September 2017 and January 2020 were enrolled in this RCT at a high-volume hospital in China. The short-term outcomes were compared between the groups.
Results
The modified intention-to-treat analysis included data from 283 patients (RDG group: n=141) and (LDG group: n=142). Patients in the RDG group exhibited faster postoperative recovery, milder inflammatory responses, and reduced postoperative morbidity (9.2% vs. 17.6%, respectively, p=0.039). Higher extraperigastric lymph nodes (LNs) were retrieved in the RDG group (17.6 ± 5.8 vs. 15.8 ± 6.6, p=0.018) with lower noncompliance rate (7.7% vs. 16.9%, respectively, p=0.006). Additionally, patients in the RDG group were more likely to initiate adjuvant chemotherapy earlier (median [interquartile range] postoperative days: 28 [24-32] vs. 32 [26-42], p=0.003). Although total hospital costs were higher in the robotic group than in the laparoscopic group, the direct cost was lower for RDG than for LDG (all p<0.001).
Conclusions
RDG is associated with a lower morbidity rate, faster recovery, milder inflammatory responses, and improved lymphadenectomy. Additionally, faster postoperative recovery in the RDG group enables early initiation of adjuvant chemotherapy. Our results provide evidence for the application of RDG in patients with GC.
Clinical trial identification
NCT03313700.
Legal entity responsible for the study
The authors.
Funding
Scientific and Technological Innovation Joint Capital Projects of Fujian Province.
Disclosure
All authors have declared no conflicts of interest.
79O - Clinical performance of Immunoscore® in early colon cancer in the Asian population (ID 527)
- Jerome Galon (Paris, France)
Abstract
Background
Immunoscore® is an in vitro diagnostic test predicting the risk of relapse in early-stage Colon Cancer (CC), by measuring the host immune response at the tumor site. This risk-assessment tool provides independent and superior prognostic value than the usual risk parameters and is intended to be used as an adjunct to the TNM classification for clinical decision. In the present study, we investigated Immunoscore® clinical performance in the Asian population from the international SITC-led validation study (Pagès et al. The Lancet 2018).
Methods
Out of the 2681 eligible stage I-III patients of the international Immunoscore® study, 423 were collected from 4 expert centers in Asia including Japan (n=330), China (n=35), and India (n=58). Patients were classified by Immunoscore® based on pre-defined cutoffs, either in 5 (IS 0-4) or 2 categories: IS Low (IS 0-1) and IS High (IS 2-4). Time to recurrence (TTR) was compared between Immunoscore® categories.
Results
Immunoscore® Low and High were observed in 37% (n=158) and 63% (n=265) of the Asian cohort, respectively. Immunoscore® was positively and significantly correlated with TTR. After 5 years, 86.9% (95% CI 82.7-91.4), and 77% (95% CI 70,5-84,1) of Immunoscore -High and -Low patients respectively were event free (HR =0.52; 95% CI 0.32-0.86; p=0.0085). When adjusting the model with Immunoscore®, age, gender, T-stage, N-stage, sidedness and MSI, and when stratified by center, Immunoscore® remained a significant parameter (HR=0.45; 95% CI 0.22-0.91; p=0.027). When stratified into 5 Immunoscore® categories, TTR rates at 5 years were 100%, 96%, 84%, 80%, and 73.5% for IS4, IS3, IS2, IS1, IS0, respectively. These results were similar to those found in European and North American patients.
Conclusions
Immunoscore® is a strong prognostic indicator of the risk of recurrence in stage I-III CC patients who receive standard of care treatment in real-life clinical practice in Asia. This first standardized immune-based assay risk assessment tool can be used reliably to guide clinical decision according to each patient information.
Legal entity responsible for the study
INSERM.
Funding
French National Institute of Health and Medical Research, the LabEx Immuno-oncology, the Transcan ERAnet Immunoscore European project, Association pour la Recherche contre le Cancer, CARPEM, AP-HP, Institut National du Cancer, Italian Association for Cancer Research, national grants and the Society for Immunotherapy of Cancer.
Disclosure
J. Galon: Shareholder/Stockholder/Stock options: HalioDx; Advisory/Consultancy: Amgen; BMS; CatalYm GmbH; Gilead; GSK; Licensing/Royalties: INSERM; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Imcheck Therapeutics; Research grant/Funding (institution): IObiotech; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Perkin-Elmer; Advisory/Consultancy: Northwest Biotherapeutics; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. Y. Kawakami: Honoraria (self): AstraZeneca; Bristol-Myers Squibb; Chugai Pharma; MSD; Ono Pharmaceutical; Sumitomo Dainippon Pharma; Taiho Pharmaceutical; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Ono Pharmaceutical. B. Mlecnik: Licensing/Royalties: INSERM. F. Marliot: Travel/Accommodation/Expenses: HalioDx. C.B. Bifulco: Shareholder/Stockholder/Stock options: PrimeVax; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: PrimeVax; Licensing/Royalties: Providence Health & Services. A. Lugli: Honoraria (self): 3DHISTECH; Sakura; Sysmex; Advisory/Consultancy: Amgen. A. Hartmann: Honoraria (self): AbbVie; Honoraria (self): AstraZeneca; Honoraria (self): BMS; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Ipsen; Honoraria (self): Janssen-Cilag; Honoraria (self): MSD; Honoraria (self): Roche; Advisory/Consultancy: 3DHISTECH; Advisory/Consultancy: AstraZeneca, Bristol-Myers Squibb, Cepheid, Diaceutics, Illumina, Ipsen, Janssen-Cilag, MSD, NanoString Technologies, Qiagen, Roche; Research grant/Funding (institution): AstraZeneca; BioNTech AG; Cepheid; Janssen-Cilag; NanoString Technologies; Roche; Advisory/Consultancy: NanoString Technologies. M. van den Eynde: Honoraria (self): HalioDx. M.H.A. Roehrl: Honoraria (self): Gerson Lehrman Group; Advisory/Consultancy: Proscia; Advisory/Consultancy: Trans-Hit; Advisory/Consultancy: UDX. F. Marincola: Leadership role, Full/Part-time employment, Investigator in AbbVie sponsored cl. trials: AbbVie. P.A. Ascierto: Shareholder/Stockholder/Stock options: PrimeVax; Advisory/Consultancy: 4SC; Alkermes; Amgen; Array BioPharma; AstraZeneca; Bristol-Myers Squibb; Genmab; Idera; Immunocore; Incyte; Italfarmaco; MedImmune; Merck Serono; Merck Sharp & Dohme; Nektar; Newlink Genetics; Novartis; Pierre Fabre; Roche/Genentech; Sandoz; Sanofi; Sun; Research grant/Funding (institution): Array BioPharma; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Roche/Genentech; Travel/Accommodation/Expenses: Merck Sharp & Dohme. B.A. Fox: Leadership role, Shareholder/Stockholder/Stock options, Full/Part-time employment: UbiVac; Shareholder/Stockholder/Stock options: PrimeVax; Honoraria (self): Janssen Biotech; Honoraria (self): Nodality; Advisory/Consultancy: AstraZeneca; Bayer; Bristol-Myers Squibb; Celldex; Definiens; Incyte; Macrogenics; MedImmune; OncoSec; Turnstone Bio; Ultivue; Research grant/Funding (institution): Akoya Biosciences; Bristol-Myers Squibb; DEfiniens; Janssen Biotech; Macrogenics (Inst); MedImmune (Inst); Merck; NanoString Technologies; OncoSec; Perkin Elmer; Shimadzu; Viralytics; Licensing/Royalties, patent licensed to UbiVac: Providence Health System; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Definiens; NanoString Technologies. F. Pagès: Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy: Gilead Sciences; Advisory/Consultancy: Janssen; Advisory/Consultancy: Merck; Advisory/Consultancy: Roche; Research grant/Funding (institution), Travel/Accommodation/Expenses: HalioDx; Licensing/Royalties: INSERM. All other authors have declared no conflicts of interest.
Invited Discussant abstracts LBA2, 114O and 79O (ID 1067)
- Sara Lonardi (Padova, Italy)
LIVE Q&A (ID 1068)
- Su Pin Choo (Singapore, Singapore)