Leading experts recommend including new drug camrelizumab in Clinical Guidelines for esophageal cancer

The journal Malignant Tumors has published recommendations presented by the Expert Board^[1] following a nation-wide discussion the leading oncologists held to address treatment options for esophageal cancer. Modern approaches for treating this malignancy do not ensure favorable results long-term. To expand treatment options, the Expert Board has recommended to include the new drug camrelizumab in the Clinical Guidelines for esophageal cancer.

The recommendations the Expert Board has prepared are based on results of different clinical studies where camrelizumab showed a reduced risk of disease progression and death. This immuno-oncology drug, the PD-1 receptor antibody, reactivates tumor-specific cytotoxic Т cells in a tumor microenvironment and, therefore, stimulates antitumor immunity. It can be used either as a first-line or second-line therapy option, which currently provide a significantly limited effect as only 22% of patients now receive this treatment^[2].

The drug was authorized in Russia in November 2024^[3]. In December of the same year, the Russian Society of Clinical Oncology (RUSSCO) included the drug in its practical guidelines^[4] in combination with gemcitabine and cisplatin as the most preferred first-line nasopharyngeal cancer therapy regimen.

Esophageal cancer is the 11th most common cancer worldwide and ranks 7th in terms of mortality^[5]. More than a half of Russian patients get diagnosed at stage III or IV when therapy options are limited^[6]. Every second patient dies within a year once the disease has been detected, while the five-year survival rate is 21.6%^[7]. This is why clinical practice urgently needs new treatment methods.

Camrelizumab reduces the risk of disease progression and death by 31%^[8] according to ESCORT, a phase 3 open-label randomized multicenter study investigating patients with metastatic esophageal cancer who did not respond to the first-line therapy. The study showed that the median total survival rate in patients receiving the camrelizumab therapy was higher than in the control group received chemotherapy with docetaxel or irinotecan.

Another study ESCORT-NEO has demonstrated that camrelizumab in combination with chemotherapy allows to significantly increase the rate of pathological complete responses vs. chemotherapy only, making 28% and 4.7%, respectively. Investigators also have noted that adding camrelizumab does not change the adverse event rate, which is why the expert community has classified the safety level of this combined regimen as good^[9].

Reference information

The immuno-oncology drug Areima^® (camrelizumab) was authorized in Russia in 2024 as an agent used to treat regional and metastatic esophageal squamous cell cancer in combination with paclitaxel and cisplatin, as well as recurrent and metastatic nasopharyngeal cancer in combination with cisplatin and gemcitabine.

The drug underwent international clinical studies, including those in Russia^[10]. The study program is currently ongoing worldwide and includes more than 400 registered studies^[11] of the drug worldwide for the treatment of various malignancies, including nasopharyngeal carcinoma, esophageal cancer, stomach cancer, liver cancer, lung cancer and other types of cancer. Camrelizumab has already been used in more than 300 thousand patients in clinical practice.

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¹ Resolution of the Expert Board on Modern Approaches to Esophageal Cancer Treatment. Malignant tumors. 2024; 14(4):91-94.https://doi.org/10.18027/2224-5057-2024-031

² Obermannová R, Alsina M, Cervantes A, Leong T, Lordick F, Nilsson M, van Grieken NCT, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Oesophageal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct; 33(10):992-1004. doi: 10.1016/j.annonc.2022.07.003. Epub 2022 Jul 29. PMID: 35914638.

³ https://petrovax.ru/press_centre/news/2024/areima/

⁴ L. V. Bolotina et al. HEAD AND NECK TUMORS. Practical Guidelines of RUSSCO. https://www.malignanttumors.org/jour/article/view/1365/

⁵ Malignant Neoplasms in Russia in 2022 (Morbidity and Mortality). Edited by A. D. Kaprin, V. V. Starinsky, A. O. Shakhzadova, I. V. Lisichnikova. 2023.

⁶ Malignant Neoplasms in Russia in 2022 (Morbidity and Mortality). Edited by A. D. Kaprin, V. V. Starinsky, A. O. Shakhzadova, I. V. Lisichnikova. 2023.

⁷ National Cancer Institute. Cancer Stat Facts: Esophageal Cancer. https://seer.cancer.gov/statfacts/html/esoph.html Access date 03.09.2024

⁸ Huang J, Xu J, Chen Y, Zhuang W, Zhang Y, Chen Z, Chen J, Zhang H, Niu Z, Fan Q, Lin L, Gu K, Liu Y, Ba Y, Miao Z, Jiang X, Zeng M, Chen J, Fu Z, Gan L, Wang J, Zhan X, Liu T, Li Z, Shen L, Shu Y, Zhang T, Yang Q, Zou J; ESCORT Study Group. Camrelizumab versus investigator’s choice of chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma (ESCORT): a multicenter, randomized, open-label, phase 3 study. Lancet Oncol. 2020 Jun; 21(6):832-842. doi: 10.1016/S1470-2045(20)30110-8. Epub 2020 May 13. PMID: 32416073.

⁹ Li Y, Qin J, Xue L, et al. Chemotherapy plus camrelizumab versus chemotherapy alone as neoadjuvant treatment for resectable esophageal squamous cell carcinoma (ESCORT-NEO): A multi-center, randomized phase III trial. J Clin Oncol. 2024; 42(suppl 3):LBA244. doi:10.1200/JCO.2024.42.3_suppl.LBA244

¹⁰ https://clinicaltrials.gov/search?intr=Camrelizumab

¹¹ https://clinicaltrials.gov/search?intr=Camrelizumab