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SHR-1701 plus chemo suppressed chemo-associated myelosuppression in patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Among patients with HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, the bifunctional PD-L1 and TGF-ß targeted agent, SHR-1701, plus chemotherapy suppressed chemotherapy-associated myelosuppression, according to data from a multicenter, 2-part phase 3 trial presented at the 2025 ASCO Gastrointestinal Cancer Symposium.
At the data cutoff of May 20, 2024, the median treatment exposure to SHR-1701 plus placebo was 137 days; 122 days for capecitabine; and 107 days for oxaliplatin in the SHR-1701 plus CAPX group. In the placebo plus CAPOX group, these numbers were 127.5, 122 and 108.5 days.
Median treatment cycles in the SHR-1701 plus CAPOX group for SHR-1701, capecitabine, and oxaliplatin treatment were 7, 6 and 6 days, respectively; however, in the placebo plus CAPOX group, the median treatment cycles were all 6 days, respectively.
CAPOX: a chemotherapy regimen that combines the drugs capecitabine and oxaliplatin.
ECOG performance status: a medical scale to assess a patient's functional ability and level of activity evaluating their ability to perform daily tasks and care for themselves.
Intravenous (IV): a method of delivering fluids, drugs, or blood into the bloodstream through a vein.
Median relative dose intensity in the SHR-1701 plus CAPOX group for SHR-1701, capecitabine and oxaliplatin was 94.5%, 83.4% and 91.1%, respectively. In the placebo plus CAPOX group, the median treatment cycles for placebo, capecitabine, and oxaliplatin were 94.4%, 83.6% and 90.6%.
Additionally, in the SHR-1701 plus CAPOX group and placebo plus CAPOX group, treatment-related side effects leading to treatment delays were platelet count decrease (20.6%; 32%), neutrophil count decrease (8%; 11.7%) and white blood cell count decrease (7.1%; 9%). Treatment-related side effects leading to treatment reductions in were platelet count decrease (15.7%; 17.8%), neutrophil count decrease (7.4%;10.1%) and white blood cell count decrease (1.9%; 1.1%) in the SHR-1701 plus CAPOX and placebo plus CAPOX groups.
“SHR-1701 showed the capacity to suppress chemo-associated myelosuppression, as evidenced by: fewer chemo delays and dose reductions; lower frequency of any grade, grade 3 [severe] or higher, and serious treatment-related hematological toxicities, including decreased platelet count, decreased neutrophil count, and decreased [white blood cell] count,” lead study author Dr. Zhi Peng, an associate professor at Beijing Cancer Hospital, Peking University, and principal investigator of the study wrote in the presentation.
Patients were randomly assigned to one of two groups and received either 30 milligrams per kilogram of intravenous (IV) SHR-1701 (364 patients) or IV placebo (366 patients) given on day 1 every three weeks with CAPOX chemotherapy. Patients were eligible for enrollment so long as they were 18 years or older with HER2-negative, unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma and no prior systemic treatment. Patients also had to have an ECOG performance status of 0 or 1 and at least one measurable lesion.
Treatment-related decreased platelet counts of any grade occurred in 59.6% of participants enrolled on the SHR-1701/CAPOX group and 68.3% of those on the placebo/CAPOX group; of grade 3 or higher in 19% and 28.1%, respectively (difference, –9.1%); and of serious indication in 6.9% and 9%, respectively (difference, –2.1%).
Treatment-related decrease in neutrophil count of any grade occurred in 44.8% of the SHR-1701 plus CAPOX group and 54.9% of the placebo plus CAPOX group. Regarding grade 3 or higher decrease in neutrophil count, this occurred in 12.1% and 16.4%, respectively, of patients in each group.
Treatment-related decrease in white blood cell count due to any grade occurred in 40.4% of participants in the SHR-1701 plus CAPOX group and 51.6% of those in the placebo plus CAPOX group. Treatment-related decrease in grade 3 or higher white blood cell count occurred in these groups, respectively at 3.6% and 5.2%.
Per the safety summary, in the SHR-1701/CAPOX group, 97.8% treatment related side effects of any grade occurred versus 98.4% in the placebo plus CAPOX group; of grade 3 or higher occurred in 62.6% and 59%, respectively; serious treatment related side effects occurred in 34.9% and 24%; and serious. Treatment related side effects occurred in 34.9% and 24%. Treatment related side effects led to discontinuation of study medication in 10.4% and 3%, respectively; SHR-1701 and placebo was discontinued in 8.2% and 1.9%; CAPOX was discontinued in 4.4% of the SHR-1701 and CAPOX group and 1.6% of the placebo/CAPOX group. TRAEs led to death in 1.9% and 1.1%, respectively.
Previously, the trial met its primary end point of superior overall survival for SHR-1701 plus CAPOX versus placebo plus CAPOX in this patient population and for those with a PD-L1 combined positive score of 5 or more and in the intent-to-treat population.
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“Effect of SHR-1701 on chemotherapy (chemo)-induced myelosuppression: data from a phase 3 study in HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA).” By Dr. Peng Z, et al. J Clin Oncol. 2025;43(4):335
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