Gastrointestinal tumours, non-colorectal


Sintilimab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First Results of the Phase 3 ORIENT-15 study

L. Shen, et al.


OS, PFS and ORR are all significantly improved in S+C vs C, with a manageable safety profile in the pts with PD-L1 CPS ≥10 and all pts. Especially the HR of OS is less than 0.7 in all pts. The results demonstrate that the combination of sintilimab and chemo can be considered as a new 1L treatment in patients with advanced or metastatic ESCC.



Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): first results of a randomized, double-blind, phase 3 study

J. Xu, et al.


Sintilimab is the first PD-1 inhibitor that demonstrated superior OS and PFS with an acceptable safety profile, in combination with chemo, in Chinese pts with G/GEJ cancer regardless of PD-L1 expressions. Sintilimab plus chemo provides a new standard first-line treatment option for these pts.



Ipilimumab or FOLFOX in combination with Nivolumab and Trastuzumab in previously untreated HER2 positive locally advanced or metastastic EsophagoGastric Adenocarcinoma (EGA) – results of the randomized phase 2 INTEGA trial (AIO STO 0217).

A. Stein, et al.


Trast/nivo/FOLFOX showed increased efficacy compared to the ToGA regimen, whereas trast/nivo/ipi did not improve OS over trast/chemo. Subgroupanalyses are ongoing and will be presented.



Primary Analysis of a Phase 2 Single-Arm Trial of Trastuzumab Deruxtecan (T-DXd) in Western Patients (Pts) With HER2-Positive (HER2+) Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Cancer Who Progressed on or After a Trastuzumab-containing Regimen

E. van Cutsem, et al.


T-DXd demonstrated clinical efficacy and a manageable safety profile in 2L treatment of Western patients with HER2+ unresectable/metastatic gastric/GEJ cancer.



JUPITER-06: A Randomized, Double-blind, Phase 3 Study of Toripalimab versus Placebo In Combination with First-Line Chemotherapy for Treatment Naive Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

R-H. Xu, et al.


The addition of toripalimab to standard first-line chemotherapy in patients with ESCC showed superior PFS and OS over chemotherapy alone with a manageable safety profile. These results support the use of toripalimab with TP chemotherapy as a new first-line treatment for advanced or metastatic ESCC.



Nal-IRI with 5-fluorouracil (5-FU) and leucovorin or gemcitabine plus cisplatin in advanced biliary tract cancer – final results of the NIFE-trial (AIO-YMO HEP-0315) - a randomized phase II study of the AIO biliary tract cancer group

L. Perkhofer, et al.


In the phase II NIFE trial nal-IRI/5-FU/LV showed efficacy as 1st-line treatment of advanced BTC with no new safety findings. ECCA and ICCA responded differently to drug interventions, with a clear benefit for nal-IRI/5-FU/LV in ECCA.



IMMUTACE: A biomarker-orientated, multi center phase II AIO study of transarterial chemoembolization (TACE) in combination with nivolumab performed for intermediate stage hepatocellular carcinoma (HCC)

A. Vogel, et al.


The study met its primary EP and provides evidence for the efficacy of TACE in combination with nivolumab without new safety signals in pts with intermediate HCC and no prior systemic therapy. Our findings support further evaluation of nivolumab- based combinations for the treatment of intermediate HCC.