The PD-1 inhibitor is being studied in multiple cancers; FDA is reviewing an application of a combination with rivoceranib in unresectable hepatocellular carcinoma.
Giving the PD-1 inhibitor camrelizumab with chemotherapy before surgery for locally advanced esophageal squamous cell carcinoma (ESCC) offered better responses than chemotherapy alone, according to phase 3 results being presented today1 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), being held in San Francisco, California.
When surgery is possible in ESCC, offering chemotherapy or chemoradiotherapy beforehand is the standard of care, but recurrence occurs in a subset of patients. This phase 3, open-label, randomized trial followed promising phase 2 results published in March 2022 (ChiCTR1900026240).2
Camrelizumab, from Elevar Therapeutics, is approved for 8 indications in China, where about half of the worldwide cases of ESCC occur. The FDA has accepted a new drug application (NDA) for the tyrosine kinase inhibitor rivoceranib in combination with camrelizumab as a frontline treatment for patients with unresectable hepatocellular carcinoma (HCC), Elevar Therapeutics, Inc., announced in a July 2023 press release. FDA’s target action date for this combination in unresectable HCC is May 16, 2024. A pair of posters offering updated data from the phase 3 CARES study (NCT03764293) will be presented at ASCO GI tomorrow. Trials are ongoing studying carmelizumab in liver, lung, breast, and gastric cancers.
According to the abstract, patients with locally advanced ESCC were stratified by clinical stage—stages I and II, stage III, or stage IVa, and then randomized 1:1:1 into 3 groups for 2, 3-week cycles of treatment. Group A received camrelizumab, albumin-bound paclitaxel (nab-paclitaxel) and cisplatin; group B used camrelizumab, paclitaxel and cisplatin; group C received paclitaxel and cisplatin. Patients were scheduled for surgery 4 to 6 weeks following treatment. In addition, carmelizumab was given after surgery every 3 weeks for up to 15 cycles for the first 2 groups.
Co-primary end points were independently assessed pathological complete response (pCR) rate, and investigator-assessed event-free survival. The trial took place between April 2021 and August 2023, enrolling 391 patients; 132 were in group A, 130 were in group B, and 129 were in group C. Most patients had stage III cancer (71.4%; n = 279) with smaller numbers diagnosed at stage I/II (27.1%; n = 106) or stage IVa, (1.5%; n = 6). Tumors were in different location (upper thoracic esophagus, 10.5%; middle, 51.4%; and lower 38.1%).
Results. Most patients completed both neoadjuvant cycles of therapy—97% in group A, 96.2% in group B, and 94.6% in group C—and high percentages advanced to surgery—86.4% in group A, 89.2% in group B, and 79.8% in group C.
The pCR rate was significantly higher In the intention-to-treat population, in the 2 groups receiving camrelizumab: rates were 28.0% in group A, 15.4% in group B, and 4.7% in group C. Additional results showed as follows:
In patients with resectable locally advanced ESCC, investigators conluded, “neoadjuvant camrelizumab with chemotherapy showed superior pCR and a tolerable safety profile compared to neoadjuvant chemotherapy alone.”
Reference
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