ESMO Live Strike Heavy Research! The results of the Phase II study of Avelumab for the second-line treatment of MSI-H/dMMR colorectal cancer were released

The 2022 Annual Meeting of the European Society of Oncology (ESMO) was held

In recent years, the rapid development of immunotherapy is quite remarkable, in this conference, SAMCO-PRODIGE 54 research explored the application of Avelumab in the second-line treatment of patients with highly microsatellite instability/mismatch repair defect (MSI-H/dMMR) metastatic colorectal cancer (mCRC), the results of which were published as LBA 23 in the oral report session of lower gastrointestinal tumors, and edited and compiled below

The SAMCO-PRODIGE 54 study is a national multicenter, open-label Phase II clinical trial designed to evaluate the efficacy and safety

Patients with MSI-H/dMMR mCRC who developed disease progression after chemotherapy-±-targeted therapy-based first-line therapy were enrolled in randomized groups (1:1) receiving standard second-line therapy or avelumab (10 mg/kg q2w).

Figure 1 Study design

From April 2018 to April 2021, a total of 122 patients were enrolled in the mITT population, of which 61 were

Figure 2 Patient baseline

As shown in Figure 3, the ORR of the avelumab group and the control group were 29.
5% and 26.
3%, the complete response (CR) rate was 6.
5% and 5%, and the DCR was 70.
5% and 77.
3%,
respectively.

Figure 3 Optimal patient response to disease

The PFS performance of the two groups is shown in Figure 4, and after a median 33.
3 months of follow-up, the PFS of the avelumab group is better than that of the control group (p=0.
025).

Figure 4 Patients with PFS

As shown in Figure 5, in terms of disease control time, the 18-month disease sustained control rates in the avelumab group and the control group were 75% and 20%,
respectively.

Figure 5 Duration of disease control in patients

The safety analysis showed that no new safety signals were found in both groups, and the incidence of grade 3-4 adverse events in the avelumab group and the control group was 31.
7% and 53.
1%, respectively, mainly including neutropenia, fatigue, hypertension, and liver function abnormalities (Figure 6
).

Figure 6 Security analysis

SAMCO-PRODIGE 54 met its primary endpoint, and the study confirmed that avelumab was superior to second-line standard therapy
in terms of PFS in patients with MSI-H/dMMR mCRC.

ORR and DCR performance was similar in both groups, but avelumab maintained disease control
for more than 18 months in most patients.

The safety of Avelumab is manageable, and researchers will conduct follow-up analysis of the patient's biomarkers to determine the best beneficiaries and predictors
of efficacy for this treatment strategy.

1.
 J.
Taieb, et al.
Avelumab versus standard second-line treatment chemotherapy in metastatic colorectal cancer (mCRC) patients with microsatellite instability (MSI): The SAMCO-PRODIGE 54 randomised phase II trial.
LBA23 2022 ESMO Congress.

Reviewer: Jiang Zhou

Typography: Wanderer

Execution: Small garden