2022 ELCC Voice of China: List of three blockbuster studies of camrelizumab

In recent years, domestic immunotherapy drugs have made great progress in the field of non-small cell lung cancer (NSCLC).
In the field of squamous cell carcinoma of the lung, camrelizumab is the first PD-1 monoclonal antibody approved for lung cancer indications in China
.

The CameL-sq study was unveiled at the ELCC conference last year, and was officially approved as a first-line treatment indication for squamous NSCLC in December 2021.
At this year’s ELCC conference, Professor Zhou Caicun of Shanghai Pulmonary Hospital affiliated to Tongji University orally reported the OS update results
.

Yimaitongte compiled three key studies related to camrelizumab at this year's ELCC conference
.

Prof.
Caicun Zhou: Update on OS results of the CameL-sq study Background: The CameL-sq study is a phase III study in China to evaluate camrelizumab + chemotherapy versus placebo + chemotherapy in patients with advanced squamous NSCLC efficacy and safety
.

The results of the interim analysis showed that compared with placebo + chemotherapy (4.
9 months), camrelizumab + chemotherapy (8.
5 months) significantly improved the progression-free survival (PFS) of patients with advanced squamous NSCLC, which can be used for first-line use treatment
.

At this conference, Professor Zhou Caicun orally reported the updated overall survival (OS) results of the study
.

Methods: Patients with advanced squamous NSCLC who had not received prior systemic therapy were randomly assigned 1:1 to receive 4-6 cycles of carboplatin (AUC 5) + paclitaxel (175 mg/m 2 ) + camrelizumab (200 mg) or placebo every 3 weeks, followed by maintenance therapy with camrelizumab or placebo
.

Patients in the placebo arm were allowed to cross over to second-line camrelizumab after disease progression
.

The primary endpoint was PFS as assessed by BICR
.

Results of study design: At data cutoff on December 29, 2021, the median follow-up time for camrelizumab + chemotherapy (n=193) and placebo + chemotherapy (n=196) was 23.
7 months and 23.
7 months, respectively.
15.
2 months
.

Compared with placebo + chemotherapy, camrelizumab + chemotherapy significantly improved OS (27.
4 months vs 15.
5 months, HR = 0.
57, P < 0.
0001)
.

The 24-month OS rates were 53.
4% ​​vs 35.
0% in the camrelizumab+chemotherapy group and the placebo+chemotherapy group, respectively, and the 36-month OS rates were 42.
8% vs 23.
7%, respectively
.

The HR after adjustment for cross-effects was 0.
41, and there was still an OS benefit
.

OS Update Results Further analysis of the OS update results after cross-treatment showed that consistent OS improvement was observed with camrelizumab + chemotherapy versus placebo + chemotherapy in each subgroup
.

The median OS was 19.
8 months and 14.
4 months in the PD-L1 TPS <1% subgroup and 14.
4 months, respectively (HR=0.
73, 95% CI 0.
52-1.
03), and in the TPS ≥1% subgroup The median OS was not reached and 20.
1 months, respectively (HR=0.
47, 95% CI 0.
31-0.
72)
.

No new security events were observed
.

Safety analysis conclusion: Long-term follow-up found that the addition of camrelizumab to chemotherapy still showed OS benefit, and the results further support this regimen as a new first-line treatment option for patients with advanced squamous NSCLC
.

Camrelizumab enters lung sarcomatoid carcinoma with a disease control rate (DCR) of 90.
9% There is currently no optimal treatment plan
.

PD-L1 is highly expressed in PSC patients, and studies have also shown that immune checkpoint inhibitors (ICIs) have better antitumor activity in PSC patients
.

Previous studies have shown that camrelizumab + apatinib has shown good antitumor efficacy in lung cancer
.

Based on the difference in PD-L1 expression level, apatinib can be combined with camrelizumab
.

At this conference, the results of a phase II study led by Professor Zhao Mingfang from the First Affiliated Hospital of China Medical University were announced
.

This study evaluated the efficacy of camrelizumab ± apatinib in patients with PD-1-positive PSC
.

Methods: This is a single-arm, open-label, multicenter, phase II study of 18-80 years of age, ECOG PS 0-2, PD-L1 positive, histologically or cytologically confirmed stage IIIB-IV PSC Patients, regardless of previous lines of therapy, were eligible for inclusion in the study
.

1-49% of patients with PD-L1 TPS received camrelizumab (200 mg, IV, Q3W) + apatinib (250 mg, QD), and 50% of patients with PD-L1 TPS received camrelizumab Monotherapy (200 mg IV Q3W) therapy
.

The primary endpoint was ORR assessed according to RECIST v1.
1 criteria
.

Treatment Duration Results: Between September 2020 and November 2021, 16 patients (camrelizumab + apatinib, n=3; camrelizumab, n=13) included studies
.

By the time of last follow-up on November 30, 2020, 14 patients had received at least one efficacy assessment
.

The ORR of the combination group was 66.
7% (2/3), the DCR was 66.
7% (2/3), and the median duration of response (DOR) was 2.
53 months
.

The ORR in the camrelizumab group was 54.
5% (6/11), the DCR was 90.
9% (10/11), and the median DOR was 3.
19 months
.

Median PFS and OS data are immature
.

Grade 3 or 4 adverse events were increased ratio of aspartate aminotransferase (AST) to alanine aminotransferase (ALT) (1, 6.
25%), hypophysitis (1, 6.
25%), and 1.
9% (3/16) of patients occurred leading to discontinuation.
adverse drug events
.

No treatment-related deaths occurred
.

Safety analysis conclusion: Camrelizumab ± apatinib showed promising antitumor activity and manageable safety profile in PD-L1-positive PSC patients
.

The findings encourage the use of this combination therapy in PSC patients in clinical practice
.

Real World Study: Efficacy of Camrelizumab in Jiangsu, China Author Information: Y.
Shu1, R.
Wang2, M.
Ji3 , M.
Shi1, X.
Zhang4.
1 Department of Oncology, Jiangsu Province People's Hospital, Nanjing, China; 2 Nanjing University, Nanjing, China; 3 The First People's Hospital of Changzhou, Changzhou, China; 4 Subei People's Hospital of Jiangsu Province, Yangzhou, China Background: Camrelizumab is a humanized PD -1 monoclonal antibody
.

The aim of this study was to analyze the antitumor activity and safety of camrelizumab in advanced lung cancer, and to explore subgroups of patients with benefit and optimal treatment
.

Methods: This is a multicenter, prospective cohort study of patients with advanced lung cancer in Jiangsu Province, China
.

Enrolled patients received at least one course of camrelizumab-containing regimen
.

Tumor response assessment (by CT or MRI) was performed every 2 or 3 months according to RECIST 1.
1
.

The primary endpoint was PFS
.

Results: Between August 7, 2019, and February 2, 2021, researchers screened 480 patients with advanced lung cancer, of which 468 were eligible and eventually included in the study
.

400 patients (85.
5%) received at least one treatment for efficacy evaluation
.

At the time of data cutoff (June 30, 2021), the median follow-up was 8.
2 months
.

In the intent-to-treat (ITT) population (n=468), 138 (29.
5%), 229 (48.
9%), and 33 (7.
1%) patients achieved partial response (PR) and stable disease (SD), respectively and disease progression (PD)
.

ORR and DCR were 29.
5% and 78.
4%, respectively
.

Median PFS was 8.
8 months (95% CI, 7.
6-10.
3) and median OS was 22.
0 months (95% CL 19.
0-not reached)
.

Grade 3 adverse events (AEs) included anemia (5.
8%, 27/468), neutropenia (3.
0%, 14/468), leukopenia (3.
0%, 14/468), thrombocytopenia (1.
7%, 8 /468), reactive cutaneous capillary hyperplasia (RCCEP) (1.
5%, 7/468), and immune checkpoint inhibitor-associated pneumonia (0.
85%, 4/468)
.

There were no treatment-related deaths.
Conclusion: This real-world study shows the current clinical practice of advanced lung cancer in China, and camrelizumab showed efficacy consistent with previous studies in patients with advanced lung cancer
.

References 1.
First-line camrelizumab plus carboplatin and paclitaxel for advanced squamous non-small cell lung cancer: Updated overall survival results from the phase III CameL-sq trial .
3MO.
2022 ELCC.
2.
Camrelizumab monotherapy or plus apatinib for PD- L1-positive advanced pulmonary sarcomatoid carcinoma: A single-arm, open-label, multicenter, phase II study.
16P.
2022 ELCC3.
Update on long term outcome of a multicentre, prospective, real-world study of camrelizumab in the treatment of patients with advanced lung cancer .
43P.
2022 ELCC.
Reviewer: XY Typesetting: XY Execution: XY