Anal cancer is expected to New PD-1 immunotherapy: Retifanlimab

Anal cancer is expected to New PD-1 immunotherapy: Retifanlimab.   Anal cancer is a kind of tumor that makes it difficult to speak. It has similar symptoms to hemorrhoids and is usually difficult to distinguish.

Recently, the US FDA announced the acceptance of the Biologics License Application (BLA) of the PD-1 monoclonal antibody Retifanlimab and granted it priority review status for the treatment of local or late metastasis that is intolerant to platinum-containing chemotherapy or the disease is still progressing after treatment Adult patients with anal squamous cell carcinoma (SCAC). It is expected to make an approval response before July 25 this year.

▌”Difficult to speak” anal cancer

Anal cancer is a malignant tumor that occurs below the dentate line of the anus, mostly caused by squamous cell carcinoma.

Anal squamous cell carcinoma (SCCA) is a cancer associated with human papillomavirus (HPV) and HIV infection, accounting for about 3% of cancers of the digestive tract. Although the incidence is increasing, it is still relatively rare.

In the early stage of anal cancer, there may be discomfort and itching in the anal area, and there may be small lumps or nodules on the edge, and the pain is mild; as the disease progresses, ulcers may form, and the pain gradually increases. Although the incidence of anal cancer is relatively low, it is highly malignant and easily confused with genital warts, thrombotic external hemorrhoids and other diseases, which greatly affect the quality of life of patients.

Currently, the treatment of anal cancer is mainly surgery/chemotherapy, and there is no approved treatment method. In addition, some patients will relapse or the disease will metastasize after standard treatment, and more effective treatments are needed to break the situation.

▌PD-1 monoclonal antibody: Retifanlimab

Retifanlimab (formerly known as INCMGA0012) is an investigational PD-1 monoclonal antibody intravenous preparation. Its efficacy is currently being evaluated in a number of clinical trials, such as monotherapy in the treatment of endometrial cancer with high microsatellite instability, Merkel cell carcinoma and anal cancer patients; or combined with platinum chemotherapy to treat patients with non-small cell lung cancer and anal cancer.

Previously, Retifanlimab was awarded the title of “Orphan Drug” by the FDA for the treatment of anal cancer.

▌Clinical data is gratifying, ORR, OS, PFS are all relieved significantly!

The submission of this BLA is based on the positive results of the Phase 2 clinical trial of POD1UM-202 (NCT03597295). The study enrolled 94 patients and evaluated the efficacy and safety of 500mg Retifanlimab in patients with locally advanced or metastatic SCAC who had previously received insufficient response or intolerance to standard platinum-based chemotherapy.

The primary endpoint is objective response rate (ORR), and secondary endpoints include duration of clinical response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS), as well as safety and pharmacokinetics dynamics. The detailed test data has been announced at the virtual meeting of the European Society of Medical Oncology (ESMO·2020).

The results show that:

The objective response rate (ORR) of Retifanlimab monotherapy in SCAC patients was 14%, including 1 complete remission and 12 partial remissions, and 35% of patients were in stable condition.

The median DOR in the treatment group was 9.5 months, the median PFS was 2.3 months, and the median OS was 10.1 months.

The point is that regardless of PD-L1 status, liver metastasis, age or HIV+ status, patients have observed a response, and the response is durable (median time is 9.5 months).

Currently, the drug’s phase 3 trial (POD1UM-303) is underway and recruiting to evaluate the efficacy and safety of Retifanlimab combined with carboplatin and paclitaxel in patients with inoperable local recurrence or metastatic anal cancer.

Although anal cancer is a rare disease, its incidence is increasing and still needs attention. Retifanlimab gives us hope for the treatment of such diseases. Once approved, it will be an important milestone in the treatment of patients with anal cancer.

▌Hemorrhoids or anal cancer?

Anal cancer is easily confused with benign lesions such as hemorrhoids. Good doctors summarized several identification methods for you:

1) The symptoms of hemorrhoids go from time to time, but the symptoms of anal cancer usually have no obvious relief and are getting worse.

2) Although both have pain and bleeding symptoms, hemorrhoids usually do not appear at the same time, and anal cancer often appears at the same time.

3) Hemorrhoids often cause itching around the anus, but anal cancer generally does not.

4) Anal cancer may be accompanied by other systemic symptoms, such as weight loss and hemorrhoids.

Of course, if you find a problem, you need to seek medical treatment in time for early detection and early treatment. Both digital anal examination and anoscope can detect anal cancer. Anal cancer can also be found during colonoscopy screening for colorectal cancer.

Good doctors reminded that healthy people began to undergo colonoscopy screening at the age of 45. High-risk groups such as HPV infection and immunocompromised persons (such as AIDS infected persons and organ transplant recipients) should increase the frequency of inspections.

In addition, HPV vaccination is very important, not only to prevent cervical cancer, but also to prevent other HPV-related cancers such as anal cancer and oral cancer.

(source:internet, reference only)

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