ELCC 2022: Summary of Clinical Research on Innovative Drugs

The CameL-sq study confirmed that for patients with squamous non-small cell lung cancer, in addition to standard chemotherapy, the combination of camrelizumab can improve the PFS of patients.

The camrelizumab group and the placebo group enrolled 193 and 196 patients, respectively, with a median follow-up of 23.

Therefore, camrelizumab combined with chemotherapy can bring continuous benefits to patients with advanced squamous non-small cell lung cancer and become one of the first-line treatment options for these patients

The ORIENT-11 study found that on the basis of first-line pemetrexed and platinum-based chemotherapy, the combination of sintilimab could improve PFS in patients with advanced non-squamous and non-small cell lung cancer.

This study included patients with untreated advanced non-squamous and non-small cell lung cancer who did not carry EGFR and ALK gene fusions.

Finally, 266 patients in the sintilimab group and 133 patients in the placebo group were enrolled.

Therefore, the ORIENT-11 study found that on the basis of traditional platinum-containing doublet chemotherapy, the further combination of sintilimab can bring OS benefits to patients

The first prespecified interim analysis of the KeyNote-598 study was conducted in September 2020.

In the study, eligible patients were divided 1:1 into ipilimumab or placebo (1 mg/kg every 6 weeks, up to 18 cycles) plus standard-dose pembrolizumab (200mg, once every 3 weeks, the upper limit of treatment is 35 cycles)

A total of 284 patients were enrolled in both groups, the data cutoff time was October 2021, and the median follow-up time was 33.

The research data confirmed the analysis data of the previous KeyNote-598 study.

Sivotinib is a highly selective inhibitor of MET mutations, and previous results have confirmed its efficacy and safety in patients with lung sarcoid-like carcinoma and other non-small cell lung cancers with MET exon 14 skipping mutations sex

In this open-label, phase II clinical study, patients who met the inclusion criteria were treated with sivotinib orally at 600 mg every 21 days, with the primary endpoint being OS

The updated data support sevolitinib as a treatment option for patients with non-small cell lung cancer with MET exon 14 skipping mutations, and benefit was observed in different subgroups with an acceptable safety profile

SH-1028 is a third-generation tyrosine kinase inhibitor targeting EGFR mutations.

From December 2009 to March 2021, a total of 228 patients were screened, 227 patients received at least 1 study drug treatment, median age was 62 years, 57.

The results of this study found that SH-1028 showed a certain clinical benefit and tolerable safety in the treatment of patients with secondary T790M mutation
.

TQ-B3101 is a novel oral small molecule tyrosine kinase inhibitor targeting targets including ALK, ROS1 and MET.
Preclinical studies have shown that the drug has broad-spectrum anti-tumor activity
.
The purpose of this study was to evaluate the efficacy and safety of its single-agent, first-line treatment in patients with ROS1-positive advanced non-small cell lung cancer
.

This is a multicenter, single-arm, phase II clinical study in patients with locally advanced or metastatic non-small cell lung cancer who have not received prior ROS1-TKI therapy
.
The therapeutic dose of TQ-B3101 is 300 mg, orally, twice a day, every 28 days as a cycle, until disease progression, intolerable toxicity or the patient withdraws informed consent
.
The primary endpoint was ORR, and secondary endpoints were DCR, DOR, median PFS, median OS, and intracranial ORR
.

As of October 2021, a total of 111 patients were treated, with a median age of 52 years, 92.
8% of patients had metastatic lesions, and 29.
7% of patients had brain metastases.
After a median follow-up of 12.
1 months, ORR reached 78.
4%, DCR 87.
4% were achieved, the median PFS assessed by the independent review committee was 15.
6 months, the median duration of response was 20.
3 months, and the median OS had not been reached, with OS rates of 98.
1% and 88.
1% at 12 and 24 months, respectively
.
Treatment-related adverse reactions occurred in 99.
1% of patients, of which 45.
1% had treatment-related adverse reactions of grade 3 and above, and the incidence of serious treatment-related adverse reactions was 3.
6%.
Only 1.
8% of patients had permanent adverse reactions due to adverse reactions.
Discontinue treatment
.
The most common treatment-related adverse reactions included increased AST (73.
9%) and increased ALT (72.
1%)
.

The data found that for patients with locally advanced or metastatic non-small cell lung cancer carrying ROS1 fusion, first-line treatment with TQ-B3101 showed good efficacy and manageable safety, providing a new first-line treatment option for patients
.

In Europe and North America, the relationship between the risk of lung cancer death and targeted therapy and early screening is not yet clear.
This study used the World Health Organization death registry database to analyze the changes in the risk of lung cancer-related death in North America and Europe
.

The study included a total of 872.
5 million patients from 2015 to 2017, and the average age-standardized mortality rate was 54.
6/100,000, with large differences between countries
.
From 2000 to 2017, the age-adjusted risk of death from lung cancer continued to decrease, by -2.
3% per year in men and -0.
3% in women, and this slight decline was largely driven by U.
S.
data
.
On the contrary, registration data from 21 countries showed that the mortality rate of female lung cancer patients showed an upward trend from 2000 to 2017, especially in Spain (4.
1%) and France (3.
6%)
.
Therefore, although the overall risk of death from lung cancer is decreasing in Europe and North America, this figure has not changed or even increased in some countries
.
This difference is mainly related to each country's tobacco control policies, disease screening, and access to treatment
.

Previous studies have confirmed the efficacy and safety of neoadjuvant osimertinib in patients with resectable EGFR-mutated non-small cell lung cancer.
This study reports the final efficacy and safety data of this single-arm, phase II clinical study.

.
The study enrolled 18-75-year-old patients with non-small cell lung cancer in stage II-IIIb stage and carrying EGFR gene mutation, who received osimertinib 80mg, orally, once a day for 6 weeks, and then received osimertinib.
surgical treatment
.
The primary endpoint was ORR, and secondary endpoints were safety, R0 resection rate, quality of life, primary pathologic response rate, complete pathologic response rate, and downstaging rate in N2 patients
.

From October 2018 to June 2021, a total of 88 patients were screened, and 40 patients were finally enrolled
.
Thirty-eight patients completed 6 weeks of osimertinib neoadjuvant therapy with an ORR of 71.
1%, and 32 patients eventually underwent surgery, 50% of which were thoracotomy, with an R0 resection rate of 93.
8%
.
Among the 28 patients who underwent postoperative pathological evaluation, the main pathological response rate was 10.
7%, of which 3.
6% were assessed as complete pathological response, and the proportion of patients with a pathological response depth of more than 50% accounted for 46.
4%.
Treatment-related adverse reactions The incidence rate was 60%, and 7.
5% of the patients had grade 3 or above adverse reactions
.

This study found that osimertinib has certain efficacy and acceptable safety in the neoadjuvant treatment of patients with stage II-IIIb, and has certain application prospects
.

Source: Editorial Department of "Tumor Watch"