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Apatinib plus camrelizumab (SHR-1210) for unresectable high-grade osteosarcoma (APFAO) progressing after chemotherapy: A prospective, open label, phase II trial.

11013 Background: Results of previous study showed high objective response but short-term activity of apatinib in advanced osteosarcoma. Given the recent success of immunotherapies, combinations of antiangiogenics with immune checkpoint blockers have become an attractive strategy. We aimed to investigate the activity of apatinib in combination with camrelizumab in patients with inoperable high-grade osteosarcoma progressing after chemotherapy. Methods: We did this open-label phase 2 trial in Peking University People’s Hospital. We enrolled patients (≥14 years) with advanced osteosarcoma progressing after chemotherapy. Patients received 500 mg apatinib orally taken once daily plus 200 mg camrelizumab intravenous infusion every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was 6 month progression-free survival (PFS). All analyses were intention-to-treatment. This trial is registered with ClinicalTrials.gov. (NCT03359018). Results: We enrolled 41 patients between January 1, and September 4, 2018. 20 (48.8%, 95%CI 32.8%-64.8%) of 41 patients were progression free at 6 months. Until final follow-up, the objective response rate was 21.95% (9/41). And the 6-m PFS rate and 4-m PFS rate were 54.32% (95% CI 37.62%-68.33%) and 70.00% (95% CI 53.24%–81.73%) respectively. Median PFS was 6.50 (95% CI 4.23–7.50) months while the median OS has not reached yet. And there were no statistical differences in the response rates or PFS between different PD-L1 expression groups ( P=0.153 and 0.231). Whereas target lesions with only pulmonary metastasis had obviously longer PFS than those lesions located at other places ( P <0.001). We also summarized all those lesions’ progression patterns as follows: slow pulmonary lesions’ progression(N=7), stable disease with lung but new lesions outside lung(N=4) and bone lesions’ progression(N=13), of which we found that there was obvious difference in PFS ( P=0.009) between different progression groups.Toxic effects led to dose reductions, or short interruptions, or both in 20 (48.78%) of 41 patients. There were no treatment-related deaths. Conclusions: The combination of apatinib and camrelizumab obviously prolonged PFS than single apatinib in the treatment for patients with advanced osteosarcoma progressing after chemotherapy. Those with pulmonary metastatic lesions obviously had longer PFS. Whether patients benefit from overall survival needs further observation. Clinical trial information: NCT03359018.