Cervical cancer immunotherapy welcomes new progress, and the BLA of batilimumab has been granted priority review by the FDA

Recently, Agenus announced that the FDA has accepted its PD-1 monoclonal antibody balstilimab (batilimumab) to treat recurrent or metastatic cervical cancer that has progressed during or after chemotherapy a biological product license application (BLA), and at the same time The FDA granted priority review to the BLA, and the PDUFA date is December 16, 2021
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Balstilimab (Batilimumab) is a new fully human monoclonal immunoglobulin G4 (IgG4) developed by Agenus.
It is designed to block the interaction of PD-1 with its ligands PD-L1 and PD-L2.
Developed as a monotherapy and combined anti-CTLA4 therapy zalifrelimab (AGEN1884) to treat cervical cancer
.

Previously, the FDA has granted balstilimab and zalifrelimab fast track qualifications for the treatment of cervical cancer

The balstilimab BLA is based on the updated data published at the European Society of Medical Oncology (ESMO) online conference in 2020 and published in the Oncogene journal, including data from a key phase II single-arm clinical trial.
The data shows that balstilimab has the ability to compete with other anti-PD- 1 Potential differences in antibodies
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Overall data showed that the remission rate of PD-L1 positive tumors was 20%, the remission rate of all tumors (PD-L1 positive and negative) was 15%, and the median duration of response was 15.

In June 2020, Betta Pharmaceuticals and Agenus reached a cooperation agreement to obtain the rights and interests of balstilimab and the CTLA-4 antibody Zalifrelimab in Greater China
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At present, balstilimab has been clinically approved in China

Cervical cancer immunotherapy has been approved, and there are many in research

Cervical cancer originates from cervical cells and is one of the most common gynecological malignancies.
In 2020, there will be 600,000 new cases worldwide and 340,000 deaths
.

The early stage of cervical cancer is mainly radical surgery, and the late stage is mainly radiotherapy

Immunotherapy is a new method of treating cancer, which relies on the ability of the immune system to directly recognize and kill tumor cells
.

In recent years, with the development of immunotherapy, the first cervical cancer immunotherapy has come out, namely Merck’s PD-1 monoclonal antibody Keytruda (pembrolizumab)

In addition to balstilimab and Keytruda, there are a number of PD-1 monoclonal antibodies under development around the world that have been developed for the treatment of cervical cancer, such as Libtayo (cemiplimab), carrelizumab, sintilizumab, and nivolumab, etc.

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Among them, Libtayo (cemiplimab) monotherapy has achieved positive results in phase 3 clinical trials of cervical cancer: Compared with chemotherapy, Libtayo significantly improves the overall survival, progression-free survival (PFS) and objective response rate (ORR) of patients with cervical cancer.

In addition, anti-CTLA-4 monoclonal antibodies (such as IBI310, zalifrelimab) and anti-TIGIT monoclonal antibodies (such as Tiragolumab, BGB-A1217) have also been developed for the treatment of cervical cancer
.

A randomized, double-blind, controlled multi-center phase II pivotal clinical study (NCT04590599) of Cinda Biologics IBI310 (anti-CTLA-4 monoclonal antibody) combined with Sintilimab for the treatment of second-line and above advanced cervical cancer is ongoing

In addition to the monoclonal antibodies mentioned above, targeting bispecific antibodies such as PD-1/CTLA-4, PDL1/TGF-β, etc.
have also been developed for the treatment of cervical cancer
.

Among them, Kangfang Bio's PD-1, CTLA-4 targeting bispecific antibody Cadonilimab (AK104) was approved in the United States for the addition of platinum-containing chemotherapy with or without bevacizumab as the first-line treatment for persistent, recurrent or metastatic cervical cancer A randomized, double-blind, placebo-controlled global phase III clinical study

Not only immunotherapy in cancer has made some progress in the field, such as antibody-drug conjugates (ADC) of this new therapy in cervical cancer has also made no small progress, which ADC drugs Seagen / Genmab A / S of tisotumab vedotin treatment BLA for recurrent or metastatic cervical cancer that progressed during or after chemotherapy was accepted by the FDA in April this year and was granted priority review qualification
.
Tisotumab vedotin is an ADC drug under development that targets tissue factor (TF).
It combines Genmab’s TF targeting monoclonal antibody tisotumab and Seattle Genetics’ ADC technology to target TF antigens on cancer cells, and The cytotoxic agent MMAE (monomethyl auristatin E) is delivered directly into cancer cells
.