SHR-1701 plus chemo suppressed chemo-associated myelosuppression in HER2-negative gastric or GEJ adenocarcinoma.
Amongst sufferers with HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, the bifunctional PD-L1 and TGF-ß focused agent, SHR-1701, plus chemotherapy suppressed chemotherapy-associated myelosuppression, in accordance with knowledge from a multicenter, 2-part section 3 trial offered on the 2025 ASCO Gastrointestinal Most cancers Symposium.
On the knowledge cutoff of Could 20, 2024, the median remedy publicity to SHR-1701 plus placebo was 137 days; 122 days for capecitabine; and 107 days for oxaliplatin within the SHR-1701 plus CAPX group. Within the placebo plus CAPOX group, these numbers had been 127.5, 122 and 108.5 days.
Median remedy cycles within the SHR-1701 plus CAPOX group for SHR-1701, capecitabine, and oxaliplatin remedy had been 7, 6 and 6 days, respectively; nonetheless, within the placebo plus CAPOX group, the median remedy cycles had been all 6 days, respectively.
Glossary:
CAPOX: a chemotherapy routine that mixes the medicine capecitabine and oxaliplatin.
ECOG efficiency standing: a medical scale to evaluate a affected person’s purposeful means and degree of exercise evaluating their means to carry out day by day duties and look after themselves.
Intravenous (IV): a technique of delivering fluids, medicine, or blood into the bloodstream via a vein.
Median relative dose depth within the SHR-1701 plus CAPOX group for SHR-1701, capecitabine and oxaliplatin was 94.5%, 83.4% and 91.1%, respectively. Within the placebo plus CAPOX group, the median remedy cycles for placebo, capecitabine, and oxaliplatin had been 94.4%, 83.6% and 90.6%.
Moreover, within the SHR-1701 plus CAPOX group and placebo plus CAPOX group, treatment-related unintended effects resulting in remedy delays had been platelet depend lower (20.6%; 32%), neutrophil depend lower (8%; 11.7%) and white blood cell depend lower (7.1%; 9%). Remedy-related unintended effects resulting in remedy reductions in had been platelet depend lower (15.7%; 17.8%), neutrophil depend lower (7.4%;10.1%) and white blood cell depend lower (1.9%; 1.1%) within the SHR-1701 plus CAPOX and placebo plus CAPOX teams.
“SHR-1701 confirmed the capability to suppress chemo-associated myelosuppression, as evidenced by: fewer chemo delays and dose reductions; decrease frequency of any grade, grade 3 [severe] or larger, and severe treatment-related hematological toxicities, together with decreased platelet depend, decreased neutrophil depend, and decreased [white blood cell] depend,” lead research writer Dr. Zhi Peng, an affiliate professor at Beijing Most cancers Hospital, Peking College, and principal investigator of the research wrote within the presentation.
Sufferers had been randomly assigned to one in every of two teams and acquired both 30 milligrams per kilogram of intravenous (IV) SHR-1701 (364 sufferers) or IV placebo (366 sufferers) given on day 1 each three weeks with CAPOX chemotherapy. Sufferers had been eligible for enrollment as long as they had been 18 years or older with HER2-negative, unresectable domestically superior or metastatic gastric or GEJ adenocarcinoma and no prior systemic remedy. Sufferers additionally needed to have an ECOG efficiency standing of 0 or 1 and not less than one measurable lesion.
Remedy-related decreased platelet counts of any grade occurred in 59.6% of members enrolled on the SHR-1701/CAPOX group and 68.3% of these on the placebo/CAPOX group; of grade 3 or larger in 19% and 28.1%, respectively (distinction, –9.1%); and of great indication in 6.9% and 9%, respectively (distinction, –2.1%).
Remedy-related lower in neutrophil depend of any grade occurred in 44.8% of the SHR-1701 plus CAPOX group and 54.9% of the placebo plus CAPOX group. Relating to grade 3 or larger lower in neutrophil depend, this occurred in 12.1% and 16.4%, respectively, of sufferers in every group.
Remedy-related lower in white blood cell depend resulting from any grade occurred in 40.4% of members within the SHR-1701 plus CAPOX group and 51.6% of these within the placebo plus CAPOX group. Remedy-related lower in grade 3 or larger white blood cell depend occurred in these teams, respectively at 3.6% and 5.2%.
Per the protection abstract, within the SHR-1701/CAPOX group, 97.8% remedy associated unintended effects of any grade occurred versus 98.4% within the placebo plus CAPOX group; of grade 3 or larger occurred in 62.6% and 59%, respectively; severe remedy associated unintended effects occurred in 34.9% and 24%; and severe. Remedy associated unintended effects occurred in 34.9% and 24%. Remedy associated unintended effects led to discontinuation of research medicine in 10.4% and three%, 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 demise in 1.9% and 1.1%, respectively.
Beforehand, the trial met its major finish level of superior total survival for SHR-1701 plus CAPOX versus placebo plus CAPOX on this affected person inhabitants and for these with a PD-L1 mixed constructive rating of 5 or extra and within the intent-to-treat inhabitants.
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Reference
“Impact of SHR-1701 on chemotherapy (chemo)-induced myelosuppression: knowledge from a section 3 research in HER2-negative gastric/gastroesophageal junction adenocarcinoma (G/GEJA).” By Dr. Peng Z, et al. J Clin Oncol. 2025;43(4):335
