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Phase III NSCLC immunotherapy drug inventory, come and see which drugs can be used

 Last Update: 2022-12-30
 Source: Internet
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For patients with stage III NSCLC, immunotherapy has brought epoch-making changes
.

In recent years, the incidence and mortality rate of lung cancer have been increasing, and the latest global cancer burden data in 2020 show that the number of lung cancer cases worldwide is about 2.
206 million, and the number of deaths due to lung cancer is about 1.
796 million [1].

Non-small cell lung cancer (NSCLC) accounts for about 85% of the total incidence of lung cancer worldwide, and nearly one-third of patients with NSCLC are locally advanced (stage III) non-small cell lung cancer at the time of diagnosis [2].

Concurrent chemoradiotherapy is the standard treatment for inoperable stage III.
NSCLC established since the 90s of the 20th century [3], and in recent years, the research of immunotherapy in the field of stage III.
NSCLC has not stopped, and breakthroughs
have been made.
With a number of immunotherapy drugs approved for marketing in China, the immunotherapy of phase III NSCLC has opened a new chapter
.
The following is a list of immunotherapy drugs and related research
approved in the field of phase III NSCLC.

PACIFIC study: After stage III NSCLC concurrent chemoradiotherapy, the 5-year OS rate of durvalumab treatment was 42.
9%,

and at present, concurrent chemoradiotherapy is still the standard treatment for patients with unresectable stage III NSCLC and good performance status, but the prognosis is still not very ideal
。 In December 2019, China's National Medical Products Administration (NMPA) approved durvalumab for the treatment of unresectable stage III.
NSCLC that did not progress after concurrent chemoradiotherapy, changing the treatment model
of patients with unresectable stage III.
NSCLC.
This approval is based on the results of the PACIFIC study, and in February 2022, the Journal of Clinical Oncology published detailed data from the 5-year follow-up of the PACIFIC study [4].

The PACIFIC study included 713 patients with unresectable stage III.
NSCLC who did not develop disease progression after platinum-containing concurrent chemoradiotherapy, and the efficacy and safety of
contrast valumab and placebo as consolidation therapy.
With a median follow-up of 34.
2 months, median overall survival (OS) was 47.
5 versus 29.
1 months in the durvalumab group and placebo group, respectively, and median OS was improved by 18.
4 months
with consolidation therapy with durvalumab.
The 3-year, 4-year, and 5-year OS rates in the durvalumab group were 56.
7%, 49.
7%, and 42.
9%, respectively, and the OS curve showed a long tailing effect
.
The median progression-free survival (PFS) was 16.
9 versus 5.
6 months in the durvalumab and placebo groups, and the five-year PFS rate was 33.
1 versus 19.
0 percent, respectively [4].

Figure 1.
The updated data on OS and PFS at 5-year follow-up in the PACIFIC study suggest robust and sustained OS and PFS
benefit when used after concurrent chemoradiotherapy
.
The 42.
9% of patients randomized to duvalumab were still alive at 5 years and 33.
1% were still alive without disease progression, which established a new benchmark
for standard therapy after chemoradiotherapy in patients with stage III NSCLC.

GEMSTONE-301 STUDY: Consolidation therapy with sugemalimab after concurrent or sequential chemoradiotherapy can bring PFS benefit

The emergence of the PACIFIC study has become a major milestone
in phase III unresectable NSCLC immunotherapy.
The GEMSTONE-301 study provides new evidence for immunoconsolidation therapy in patients with stage III unresectable NSCLC [5].

Based on the results of this study, in June 2022, the Chinese NMPA approved sugemalimab for consolidation therapy in patients with unresectable stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy
.

The GEMSTONE-301 study was a phase III randomized controlled trial of stage III unresectable patients who did not develop disease progression after concurrent chemoradiotherapy or sequential chemoradiotherapy, and were randomized to receive sugemalimab or placebo
.
At the interim analysis cut-off, 123 (48%) and 74 (59%) patients in the sugemalimab and placebo treatment groups had disease progression or death
, respectively.
The median PFS assessed by the Blinded Independent Centre Review Committee (BICR) were 9.
0 months and 5.
8 months, respectively, in the sugemalimab group and placebo group, with a 36% reduction in the risk of disease progression or death in the sugemalimab group and a 12-month PFS rate of 45.
4% versus 25.
6% in the sugemalimab and placebo groups; In most subgroups, sugemalimab confered significant PFS benefit
compared with placebo.
OS data were still immature at the time of data cut-off, with 32 (13 percent) and 32 (25 percent) deaths in the sugemalimab and placebo groups, respectively [5].

IMpower010 study: In PD-L1 TC≥1% of patients, adjuvant atezolizumab has brought OS benefit trend

In recent years, immunotherapy has also made many breakthroughs
in the perioperative treatment of NSCLC 。 In March 2022, the Chinese NMPA officially approved atezolizumab monotherapy for the adjuvant therapy
of patients with stage II-IIIA NSCLC who were evaluated as ≥1% of tumor cells (TC) PD-L1 stain-positive, surgically resected, and followed by platinum-based chemotherapy.
This approval is based on the results of IMpower010 research [6].

IMpower010 is a randomized, open-label, global, multicenter phase III study evaluating the efficacy and safety of adjuvant atezolizumab versus optimal supportive care (BSC) after postoperative adjuvant chemotherapy in patients with completely resected stage II-IIIA NSCLC [6].

The results of the first OS interim analysis of the IMpower010 study were reported
at this year's World Lung Cancer Congress (WCLC).
At the end of data on 18 April 2022, the median follow-up was 45 months, and 25.
0% of patients died (ITT population; N=1005), an OS-benefit trend was observed in the atezolizumab group (HR=0.
71) in PD-L1 TC≥1% of stage II-IIIA patients, with a 5-year OS rate of 76.
8
%.
In PD-L1≥50% of patients, the benefit of atezolizumab was more prominent, with OS rates of about 89.
1% at 3 and 84.
5% at 5 years
.
In terms of safety, grade 3 to 4 adverse events occurred in 22.
0 percent and 11.
5 percent of patients in the atezolizumab group and the best supportive care group, respectively, and the rate of grade 5 treatment-related adverse events in the two groups was 0.
8 percent and 0 percent, respectively [6].

total

knot

For unresectable stage III.
NSCLC, concurrent chemoradiotherapy was the standard treatment mode, but now with the intervention of immunotherapy, the survival benefit of patients has been further improved, opening a new era of
consolidation therapy for stage III.
NSCLC.
For resectable patients, immunotherapy has made a revolutionary breakthrough
in the perioperative field of stage III NSCLC with the deepening of research.
It is expected that in the near future, immunotherapy drugs can make new breakthroughs in the field of phase III NSCLC treatment, bringing survival benefits
to more patients.

References:

[1] Sung H,Ferlay J,Siegel RL,et al.
Global Cancer Statistics 2020:GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
CA Cancer J Clin.
2021; 71(3):209-249.

[2] Yan Lanfang, Wu Yun.
Current status and prospect of treatment of locally advanced non-small cell lung cancer[J].
Cancer Progress,2021,19(19):1957-1960,1973.
)

[3] YU Silai, NI Jianling, ZHU Zhengfei.
Treatment of inoperable locally advanced non-small cell lung cancer in the era of immunotherapy:Current status and prospects[J].
Chinese Journal of Oncology,2022,32(6):487-498.
)

[4] Spigel DR,Faivre-Finn C,Gray JE,et al.
Five-Year Survival Outcomes From the PACIFIC Trial:Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
J Clin Oncol.
2022; 40(12):1301-1311.

[5] Qing Zhou,Ming Chen,Ou Jiang,et al.
Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced,unresectable,stage III non-small-cell lung cancer in China(GEMSTONE-301): interim results of a randomised,double-blind,multicentre,phase 3 trial.
Lancet Oncol.
2022; 23(2):209-219.

[6] PL03.
09-IMpower010:Overall Survival Interim Analysis of a Phase III Study of Atezolizumab vs Best Supportive Care in Resected NSCLC.
2022 WCLC.

Approval number: CN-107220 Expiration Date: 2023-3-8*This material is supported by AstraZeneca, is for the reference of medical and healthcare professionals only and may not be used for promotional purposes
.

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