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Editor: Koyuan
Please do not reprint
without authorization.
The European Society of Medical Oncology (ESMO) Annual Meeting is the most prestigious and influential oncology conference
in Europe.
ESMO Conference 2022 will be held in person (Paris, France) and online from September 9 to 13, 2022
Covering basic research, translational research and the latest clinical research progress, it will provide a broad and excellent academic platform
for clinical practice and multidisciplinary discussion.
There are several blockbuster studies in the field of
.
In the morning of the 11th local time, two immunotherapy-related studies led by Professor Han Baohui and Professor
.
Yimaitong is specially organized as follows:
Professor Han Baohui's team: PD-1 inhibitor +
Professor Han Baohui
Background:
Phase I studies have shown clinical benefit
of PD-1 monoclonal antibody
Previous results showed that the combination therapy had an objective response rate (ORR) of 72.
7%, a disease control rate (DCR) of 100%, a median progression-free survival (PFS) of 15 months, an 18-month and 24-month PFS rate of 45.
9% and 262.
%, and an immature overall survival (OS) result, with an estimated 12-month OS rate of 95.
5%.
At this year's ESMO conference, Professor Han Baohui orally reported the results of a phase II randomized controlled study: the results
of a preliminary interim analysis of sindilimab + anlotinib in patients with treatment-naïve metastatic NSCLC.
Method:
This is an open-label Phase II study
conducted at 6 centers in China.
Patients with treatment-naïve stage IV, EGFR/ALK/ROS1-negative NSCLC are eligible for enrollment
.
Enrolled patients were randomized 1:1 to Group A (sindilimab 200 mg, anlotinib 12 mg, PO, D 1-14, PO, D 1-14) or B (platinum-containing chemotherapy, crossover to sindilimab allowed after disease progression).
Stratification factors include histologic type and PD-L1 expression level
.
Treatment is given every three weeks until disease progression or intolerable toxicity, discontinuation, or death
.
Sindilimab was treated for 24 months or 35 cycles
.
The primary endpoint was ORR, and secondary endpoints included PFS, DCR, duration of response (DoR), OS, and safety
.
Study design
Outcome:
Between November 2019 and July 2022, 89 included patients were randomized to Group A (43) or Group B (46).
As of July 15, 2022, the median follow-up was 13.
1 months, and 83 patients could be evaluated for efficacy (40 in group A versus 43 in group B).
。 ORRs were 50.
0% (95% CI 33.
8 to 66.
2) and 32.
6% (95% CI 19.
1 to 48.
5) in groups A and B, respectively, DoR was 16.
3 and 6.
2 months, and DCR rates were 85.
0% (95% CI 70.
2 to 94.
3) vs 93.
0% (95% CI 80.
9 to 98.
5),
respectively.
Efficacy analysis
The median PFS in both groups was 10.
8 versus 5.
7 months (HR 0.
4; 95% CI 0.
25 to 0.
74).
The OS is not yet mature
.
Secondary study endpoints
The incidence of grade 3-4 treatment-related adverse events (TRAE) in groups A and B was 11.
6% and 43.
5%,
respectively.
The most common adverse events in group A were
A.
Two patients in group B stopped treatment, one patient died of TRAE, and no discontinuation or death was
observed in group A.
Conclusion:
Preliminary interim analysis showed that sindilimab + anlotinib improved efficacy in patients with treatment-specific metastatic NSCLC compared with chemotherapy, and there was a trend of
survival benefit.
This chemotherapy-free combination has the potential to be the first-line treatment option
for metastatic NSCLC.
Professor Lu Shun's team: The ORIENT-31 study released the results of the second interim analysis, reaching the main PFS endpoint
Professor Lu Shun
Background:
Treatment options following treatment failure of EGFR-sensitive mutation non-squamous NSCLC (nsqNSCLC) TKI are limited
.
nsqNSCLC.
VEGF inhibitors not only have the effect of antivascular drugs, but also produce immunomodulatory effects
by enhancing the efficacy of T cell-mediated killing of tumor cells.
The ORIENT-31 study is a randomized, double-blind, phase III study to evaluate the efficacy and safety
of sindilimab ±IBI305 (bevacizumab biosimilar) + chemotherapy compared with chemotherapy in patients with EGFR-mutated nonsquamous NSCLC 。 The first interim analysis (IA) showed that sindilimab + IBI305+ chemotherapy significantly improved PFS in patients compared with chemotherapy, group A vs group C (PFS HR 0.
637, P< 0.
0001) (Lu, et al.
Lancet Oncol 2022）<b17>。 At this year's ESMO conference, Professor Lu Shun orally reported the results
of the second interim analysis.
Method:
Eligible enrolled patients were randomized (Phase I 1:1:1 and Phase II 2:2:1) to Group A (sindilimab + IBI305 + chemotherapy) and B (sindilimab + placebo + chemotherapy) and C (placebo 1 + placebo 2 + chemotherapy).
Enrolled patients received sindilimab/placebo 1 (200 mg), IBI305/placebo2 (15 mg/kg), pemetrexed (500 mg/m2), and
.
Subsequently, groups A, B and C received sequential cindilimab + IBI305+ chemotherapy, sindilimab + placebo 2 + chemotherapy, placebo 1 + placebo 2 + chemotherapy maintenance therapy
, respectively.
The primary endpoint was PFS
assessed according to RECIST v1.
1.
Based on a pre-developed analysis plan, the second interim analysis (announced at this year's ESMO conference) aims to evaluate the PFS of groups B and C and further confirm the conclusion
that group A is superior to group C at the time of the first interim analysis.
Study design
Outcome:
At the end of the data on March 31, 2022, 476 patients were randomly assigned to group A (158 cases), group B (158 cases), and group C (160 cases), with a median age of 57.
0 years and 37.
0% of patients had brain metastases
.
63.
0% of patients received first- or second-generation EGFR TKI (T790M negative), 26.
3% received first- or second-generation EGFR TKI followed by third-generation EGFR TKI (T790M positive), and 10.
5% received third-generation EGFR TKI first-line therapy
.
Baseline characteristics of the patient
The median follow-up was 13.
1 months, and the median PFS in groups A, B, and C assessed by the Independent Radiological Review Board (IRRC) was 7.
2 months, 5.
5 months, and 4.
3 months
, respectively.
Group B had a significantly higher median PFS compared to Group C (HR 0.
723, 95% CI: 0.
552, 0.
948; P = 0.
0181).
The study met the primary PFS endpoint
The ORRs for groups A, B and C confirmed by IRRC were 48.
1%, 34.
8% and 29.
4%,
respectively.
The DCRs of the three groups were 86.
1%, 81.
6% and 75.
6%, respectively.
The median DoR in the three groups was 8.
5 months, 7.
4 months, and 5.
7 months
, respectively.
Secondary study endpoints
The incidence of adverse events during grade 3 and above treatment in the three groups was 59.
5%, 46.
2%, and 56.
9%,
respectively.
Conclusion:
Compared with chemotherapy alone (group C), sindilimab + chemotherapy (group B) significantly improved PFS
in patients with EGFR-mutated non-squamous NSCLC after EGFR TKI treatment progression.
OS results were immature and no new adverse events
were identified.
References:
[1] LBA57-Sintilimab plus anlotinib versus platinum-based chemotherapy as first-line therapy in metastatic NSCLC （SUNRISE）: An open label, multi-center, randomized, phase II study.
2022 ESMO.
[2] LBA58-Sintilimab with or without IBI305 plus chemotherapy in patients with EGFR mutated non-squamous non-small cell lung cancer （EGFRm nsqNSCLC） who progressed on EGFR tyrosine-kinase inhibitors （TKIs） therapy: Second interim analysis of phase III ORIENT-31 study.
2022 ESMO.
