ESMO Voice of China | Socazolimab combined chemotherapy as a Chinese group analysis of neoadjuvant therapy for esophageal squamous cell carcinoma

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The 2022 European Society for Internal Oncology (ESMO) Annual Meeting was held
in Paris from September 9 to 13 local time.

As immunotherapy advances in the therapeutic application of esophageal cancer, more and more research has explored
neoadjuvant immunotherapy for esophageal cancer.

Research background

Neoadjuvant synchrotron chemoradiotherapy is currently the standard treatment strategy for patients with locally advanced ESCC, but the clinical efficacy of this strategy is not satisfactory
.

Patients with ESCC whose criteria were cT2N+M0 or cT3-4aN+/-M0 were first evaluated for safety at stage IB and subsequently assigned (1:1) to Socazolimab 5 mg/kg IV, d1 (S group), or placebo (group P), with both groups receiving simultaneous 4 cycles of preoperative chemotherapy (albumin-bound paclitaxel 125 mg/m² IV, d1, d8; cisplatin 75 mg/m² IV, d1; q21d）
。 For patients in the S group, if there are still pathological tumor remnants after surgery, Socazolimab
is continued for 12 cycles.

At the stage of IB, no dose-limiting toxicity
was observed in the first 6 patients included in the study.

Figure 1 Patient allocation

As of 5 January 2022, 29 patients (90.
6%) had undergone surgery in each of the two groups, and the R0 resection rates in groups S and P were 100% and 98.
6%,
respectively.
The tumor pathological remission of the two groups of patients was shown in Figure 2, the MPR rates of S and P groups were 68.
97% and 62.
07% (p=0.
509), pCR rates were 41.
4% and 27.
6% (p=0.
311), respectively, and the ypT0 rate of S group was significantly higher than that of P group (37.
93% vs 3.
45%, P=0.
001).

The data for the EFS and OS study are premature
.

Figure 2 Pathologic remission of tumor in patients

Safety analysis showed that the incidence of ≥grade 3 treatment-related adverse events (TRAEs) in groups S and P was 65.
5% and 62.
5%,
respectively.
The most common AEs were neutropenia (59.
4% vs 56.
3%), leukopenia (43.
8% vs 25.
0%), and hypokalemia (18.
8% vs 0
).
Two patients in each of the two groups developed major surgical complications
.

Conclusion of the study

Although the difference was not statistically significant, neoadjuvant Socazolimab combination chemotherapy showed a numerically advantageous rate of MPR and pCR in patients with locally advanced ESCC and did not increase the incidence
of perioperative complications in patients.
The researchers believe that this strategy should be further evaluated
in a phase III trial.

References

1.
 Yong Li, et al.
Neoadjuvant PD-L1 inhibitor (socazolimab) plus chemotherapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, double-blind phase II study.
1207P 2022 ESMO Congress.