Highlights of adjuvant therapy for NSCLC: Phase III clinical data of T drug approved for adjuvant immune drug K drug released

Recently, many new advances have been made in the field of adjuvant therapy for non-small cell lung cancer (NSCLC)
.
Roche's T drug (atezolizumab) was approved for adjuvant treatment of NSCLC after lung cancer surgery
.
As of the date of approval, this is the first and only adjuvant immune drug for non-small cell lung cancer approved in China, ushering in a new era of perioperative immunotherapy
.
During the same period, Merck also announced the specific data of K drug in the adjuvant (postoperative) treatment of early-stage lung cancer
.
Recently, the China National Medical Products Administration officially approved Roche's innovative tumor immune drug atezolizumab as a single drug for detection and evaluation of ≥1% tumor cells (TC) with positive PD-L1 staining, surgical resection, and platinum-based treatment.
Adjuvant therapy for patients with stage II-IIIA non-small cell lung cancer after class-based chemotherapy [1]
.
The results of the IMpower010 study showed that in patients with stage II-IIIA NSCLC whose tumors expressed PD-L1 ≥1%, atezolizumab was used as adjuvant therapy after surgery and chemotherapy, compared with the current best treatment.
Prolonged disease-free survival (DFS), reduced risk of disease recurrence or death by 34% (HR = 0.
66; 95% CI: 0.
50-0.
88), and 60% in patients without disease recurrence or death at 3 years; for PD-L1 ≥ In 50% of patients with stage II-IIIA NSCLC, the risk of disease recurrence or death was reduced by 57% (HR = 0.
43; 95% CI: 0.
27-0.
68) [2] Last October, Tecentriq became the first in adjuvant treatment of early stage NSCLC It is an immuno-oncology drug approved by the US FDA [3]
.
The same indication was officially approved in China on March 16 this year
.
Authoritative guidelines such as NCCN and ASCO have recommended atezolizumab for adjuvant treatment of patients with stage II-IIIA NSCLC with PD-L1≥1% after surgery and chemotherapy [4-5]
.
Recently, Merck announced the specific data of Keytruda in the adjuvant (postoperative) treatment of early-stage lung cancer
.
The Phase 3 KEYNOTE-091 trial met one of the co-primary endpoints of disease-free survival (DFS) in the entire patient population regardless of tumor PD-L1 expression status, according to data presented at the European Society of Medical Oncology (ESMO) plenary meeting.
), postoperative treatment with Keytruda reduced the risk of disease recurrence or death by 24% in patients with stage IB to IIIA non-small cell lung cancer (NSCLC) compared with placebo
.
The median DFS was 53.
6 months in the Keytruda group and 42 months in the placebo group, which was prolonged by nearly one year (HR=0.
76, 95%CI: 0.
63-0.
91, P=0.
0014)[6]
.
In the data published by Merck, Keytruda had a disease-free survival benefit of 18% in patients with PD-L1 expression ≥50% (HR=0.
82, 95%CI:0.
57-1.
18, P=0.
14)
.
Another co-primary endpoint of the Phase 3 KEYNOTE-091 trial, DFS in the population with PD-L1 expression ≥50%, has not shown a statistically significant difference [6]
.
How does Keytruda perform in subgroups of patients, especially those with stage IB or PD-L1-negative disease
.
Merck described Keytruda's performance across patient subgroups as "broadly converging," and given the small number of patients in each group, the analysis should not be read too much
.
According to a presentation at the ESMO plenary session, Keytruda reduced the risk of disease recurrence or death by 24% compared with placebo in patients with stage IB disease and 22% in PD-L1-negative patients [6]
.
But so far, only "T" drugs have been officially approved for supplementary indications in China
.
Earlier this month, Bristol-Myers Squibb's Opdivo received FDA approval [7] for the preoperative neoadjuvant treatment of patients with resectable NSCLC
.
It is also expected that the relevant indications of "K" drug based on Keynote-091 will be approved as soon as possible to jointly benefit lung cancer patients
.
Reference sources 1.
https:// 2.
Lancet.
2021 Oct 9;398(10308):1344-1357.
3.
https:// -approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-non-small-cell-lung-cancer 4.
NCCN Guideline NSCLC 2021 V7 5.
Katherine Pisters, et al.
J Clin Oncol.
2022 Feb15.
6.
Paz- Ares L, et al.
Abstract VP3.
2022 ESMO Virtual Plenary 7.
https:// -early-stage-non-small-cell-lung