Nearly a quarter of lung cancer patients are cancer-free after surgery!

▎The content team editor of WuXi AppTec.
Recently, the immunotherapy drug Opdivo (Navulimab) announced a positive progress in the American Association for Cancer Research (AACR) 2021 meeting.
For patients with cell lung cancer (NSCLC), immunotherapy combined with chemotherapy has the potential to become a new neoadjuvant treatment option.

The results of the CheckMate 816 randomized trial show that in patients with operable NSCLC, neoadjuvant chemotherapy combined with nivolumab can significantly increase the pathological complete remission rate to 24.
0%, which is nearly 12 times that of the chemotherapy group (2.
2%)! In other words, nearly a quarter have no signs of cancer after the final surgery.

This benefit is consistent in patients with different stages, histology, tumor mutation burden (TMB) and PD-L1 expression levels.

Among patients undergoing complete resection, the improvement brought by the combined treatment group was more obvious.

Image source: 123RF high-risk operable NSCLC patients usually need to receive neoadjuvant chemotherapy or adjuvant chemotherapy during the perioperative period.

Currently, patients urgently need better neoadjuvant therapies.

"CheckMate 816 is the first phase 3 trial showing the benefits of neoadjuvant immunotherapy combined with chemotherapy for operable NSCLC.

" said Dr.
Charles Swanton from University College London and Cancer Research UK The pathological complete remission is closely related to the survival period of NSCLC.

In previous studies, the pathological complete remission rate caused by only chemotherapy before surgery was only 4% on average.

Dr.
Patrick M.
Forde from the Sidney Kimmel Cancer Center at Johns Hopkins University added, “At present, the improvement in overall survival (OS) with systemic therapy before and after surgery is very small, only about 5%.

” Image source: Dr.
123RFForde It was introduced at the AACR conference that in this multicenter trial, researchers included patients with newly diagnosed stage Ib-IIIa NSCLC who had no EGFR or ALK mutations.

The trial evaluated the effects of preoperative chemotherapy alone and two combined treatment strategies (fixed-dose nivolumab combined with chemotherapy, and weight-adjusted nivolumab combined with ipilimumab [Yervoy]).

After imaging evaluation, the patient underwent surgery within 6 weeks, and received adjuvant chemotherapy with or without radiotherapy after surgery.

The primary endpoint of the trial is complete pathological remission and event-free survival (EFS).

Complete pathological remission is defined as the absence of visible tumor cells in the primary tumor and sampled lymph nodes (ypTON0).

The data published this time are the data of nivolumab combined with chemotherapy.

Data analysis included 358 patients.

98% of the patients received the designated treatment, of which 94% and 85% of the nivolumab combined chemotherapy group and the chemotherapy group received three planned treatment cycles.

In the combination therapy group, 83% of patients eventually underwent surgery, and only 75% of the patients in the chemotherapy group eventually underwent surgery.

The postponement rates of surgery in the two groups were 21% and 18%, respectively.

More patients in the combination therapy group (77% vs 61%) had a chance to undergo lung-sparing surgery.

The complete pathological remission rates of the combination therapy group and the chemotherapy-only group were 24.
0% and 2.
2%, respectively (OR 13.
94).

Among the patients who actually underwent surgery, the difference was even greater.
The complete pathological remission rates of the two groups were 30.
5% and 3.
2%, respectively.

In addition, the combination therapy also improved the primary pathological response (36.
9% vs 8.
9%, a secondary endpoint, defined as residual viable tumor cells in the primary tumor and lymph nodes ≤ 10%) and the overall response rate.

At present, the study continues to accumulate data for the primary endpoint of EFS.

Image source: Dr.
123RFForde pointed out that during neoadjuvant therapy, the elimination of circulating tumor DNA (ctDNA) may increase the possibility of complete pathological remission.

In the exploratory analysis, among the subgroups of patients who underwent ctDNA evaluation, the ctDNA clearance rates of the combination therapy group and the chemotherapy-only group were 56% (24 cases/43 cases) and 34% (15 cases/44 cases), respectively.

Among patients who cleared ctDNA, 11 out of 24 cases in the combined treatment group and 2 out of 15 cases in the chemotherapy group achieved complete pathological remission.

Among the patients who did not achieve ctDNA clearance, only one patient in the chemotherapy group achieved complete pathological remission.

In terms of safety, treatment-related adverse events (TRAE) are consistent with the known effects of the trial drug.

In the nivolumab combined with chemotherapy group, the incidence of grade ≥3 TRAE was 34%, compared with 37% in the chemotherapy group.

It is hoped that the longer-term efficacy data of this treatment plan in early-stage lung cancer can continue to prove the benefits, bring new options for neoadjuvant therapy to patients as soon as possible, and bring greater hope of survival for early-stage patients! Related reading "The Lancet" sub-news: led by Professor Shi Yuankai, vometinib has become a new choice for the first-line treatment of advanced lung squamous cell carcinoma after the progress of lung cancer in China! The new Chinese drug tislelizumab appeared in the "Journal of the American Medical Association-Oncology" "The Lancet-Respiratory Medicine" Professor Zhou Caicun led: overall survival prolonged by 7 months! Carrelizumab is a new choice for the first-line treatment of non-squamous NSCLC for precision treatment of lung cancer.
China's first RET inhibitor pratinib was approved.
Reference materials [1] Forde PM, et al.
, (2021).
Nivolumab + platinum- doublet chemotherapy vs chemotherapy as neoadjuvant treatment for resectable (Ib-IIIa) non-small cell lung cancer in the phase III CheckMate 816 trial.
AACR 2021; Abstract CT003.
[2] A Win for Nivolumab as Preoperative Therapy for Lung Cancer.
Retrieved April 13, 2021, from Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

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