ESMO Voice of China Prof. Liu Shuku Team/Prof. Long Hao Team: An Exploration of Neoadjuvant Immunotherapy in Early and Local Advanced Lung Cancer

Editor: Xiaoyuan

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The European Society for Internal Oncology (ESMO) Annual Meeting is the most prestigious and influential oncology conference
in Europe.

A number of blockbuster studies in the field of lung cancer will be presented at this year's ESMO conference
.

Professor Liu Shuku's team: Neoadjuvant immunotherapy is used for early lung squamous cell carcinoma, and the main pathological remission rate is 38.

Background:

Multiple studies have shown that PD-1 inhibitors plus chemotherapy are effective
in resecting non-small cell lung cancer (NSCLC).

Method:

This is a single-arm, phase II trial (ChiCTR2100044645) in which eligible patients were 18 to 70 years of age, newborne, histically proven stage IIB-IIIB LUSCs
.

Study the design

Outcome:

Between March 2021 and March 2022, a total of 26 patients
were included in the study.
At the time of the data as of April 8, 2022, all 26 patients received neoadjuvant therapy, of which 22 (22/26, 84.
6%) completed the treatment plan developed in the study and 17 patients (17/22, 77.
3%) underwent surgical resection
.
With or without resection, the MPR rate was 38.
5% (10/26, 95% CI 20.
2% to 59.
4%) and the pathological complete response (pCR) rate was 19.
2% (5/26, 95% CI 7.
6% to 39.
4%)
.
Key results

Grade 3 or 4 treatment-related adverse events (TRAE)
occurred in 10 patients (10/26, 38.
4%) and 2 (2/26, 7.
6%), respectively.
The most common TRAEs were rash (15.
4%), bone marrow suppression (11.
5%), hemoptysis (7.
7%), immune dermatitis (3.
8%), and diarrhea (3.
8%)
.
Of the 17 patients who underwent surgery, 8 (47.
1%) developed surgery-related complications, of which 6 (35.
3%) had intraoperative blood loss of > 400 ml, and 5 (29.
4%) had a postoperative indwelling catheter for 7 days
.
No unexpected safety events or treatment-related deaths occurred
.

Conclusion:

The addition of carrelizumab to neoadjuvant chemotherapy showed good antitumor activity and controllable safety
in patients with resectable LUSC.

Prof.
Long Hao's team: NeoTAP01 study announces updated results, the 2-year EFS rate of neoadjuvant immunotherapy reached 67.
9%

Background:

The NeoTAP01 study is a single-arm Phase II study designed to explore the feasibility
of the neoadjuvant PD-1 inhibitor terreprimumab + chemotherapy for stage III NSCLC.
Preliminary results from this trial, which were presented at the 2021 ASCO Conference (Summary 8541), showed a primary MPR rate of 66.
7% and a pCR rate of 50%
for those who were eligible for the protocol (PPP).
At this year's ESMO conference, the team of Professor Long Hao of the Center for Cancer Prevention and Control of Sun Yat-sen University announced the study's two-year event-free survival (EFS) rate
.

Method:

Patients with stage IIIA or T3-4N2 stage IIIB in the study included patients with
initial treatment of NSCLC.
Surgical excision
is performed 4 to 5 weeks after three cycles of neoadjuvant therapy.
The neoadjuvant regimens given on day 1 of each cycle are the PD-1 inhibitor terreprilizumab (240 mg), carboplatin (AUC 5), and pemetrexed (500 mg/m2 for adenocarcinoma) or albumin-bound paclitaxel (260 mg/m2 for other subtypes) for 21 days
per cycle.
The primary endpoint is MPR, and the secondary endpoint includes pCR rate, EFS, and safety
.

Study the design

Outcome:

As of April 15, 2022, the median follow-up time for the intended treatment population (ITT) was 16.
4 months (IQR: 12.
8-20.
0), with 33 patients (90.
9%) of enrolled patients undergoing surgical resection, of which 27 (81.
8%) received adjuvant therapy
after surgery.
Twenty-two patients (66.
7%) received 1 year of adjuvant triprimab monotherapy, and 2 patients stopped adjuvant immunotherapy after 3 months (due to grade 3 rash and pituititis).

All but one patient (3.
0%) died of disease progression during preoperative treatment, and all patients survived
.
Five patients (15.
2%) experienced disease recurrence, of which only 1 patient developed intrathoracic recurrence
.
The median EFS in the intending to treat population was not achieved, with EFS rates at 12 and 24 months at 87.
8% and 67.
9%,
respectively.
Patients who did not achieve MPR had significantly longer EFS (P=0.
02) compared with patients who did not achieve MPR (16.
6 months of EFS).

Key results

Conclusion:

Neoadjuvant teriprimab + chemotherapy has shown promising case remission
in patients with stage III NSCLC.
Most patients can tolerate neoadjuvant teriprimab monotherapy
.
MPR may serve as an alternative endpoint for long-term survival, as patients who achieve MPR have better EFS
.

References:

[1] 942P-Camrelizumab combined with albumin paclitaxel and platinum in perioperative treatment of resectable squamous cell lung cancer: A single-arm, open-label, phase II clinical trial.
2022 ESMO.

[2] 955P-Updated event-free survival of neoadjuvant toripalimab with chemotherapy for resectable stage III NSCLC (NeoTAP01 study).
2022 ESMO.