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Pyrotinib combined with apatinib for targeting metastatic non-small cell lung cancer with HER2 alterations: a
Guangjian Yang1,2, Haiyan Xu3, Yaning Yang1
1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Street South, Chaoyang District, Beijing, 100021, China.
Background:
Although targeted agents have been gradually applied in the treatment of HER2-mutated non-small cell lung cancer (NSCLC) in recent years, patients' therapeutic demands are far from being met. PATHER2 was the first phase 2 trial to explore the efficacy and safety of the HER2-targeted tyrosine kinase inhibitor (TKI) pyrotinib plus the antiangiogenic agent apatinib in previously treated HER2-altered metastatic NSCLC patients.
Methods:
HER2-mutated or HER2-amplified metastatic NSCLC patients who had failed at least first-line chemotherapy or HER2-targeted TKIs received oral pyrotinib 400 mg plus apatinib 250 mg once daily until disease progression, intolerable toxicity, or death. The primary endpoint was the investigator-assessed objective response rate (ORR).
Results:
Between March 2019 and December 2020, 33 patients were enrolled; 13 (39.4%) presented brain metastases, and 16 (48.5%) had received at least two lines of prior chemotherapy or HER2-targeted TKIs. As of September 20, 2021, the median follow-up duration was 11.3 (range, 3.5-26.0) months. The investigator-assessed ORR was 51.5% (17/33; 95% CI, 33.5 to 69.2%), and the disease control rate was 93.9% (31/33; 95% CI, 79.8 to 99.3%). The median duration of response, progression-free survival, and overall survival were 6.0 (95% CI, 4.4 to 8.6) months, 6.9 (95% CI, 5.8 to 8.5) months, and 14.8 (95% CI, 10.4 to 23.8) months, respectively. The most frequent grade ≥ 3 treatment-related adverse events included diarrhea (3.0%) and hypertension (9.1%). No treatment-related deaths were reported.
Conclusions:
Pyrotinib plus apatinib demonstrated promising antitumor activity and a manageable safety profile in HER2-mutated or HER2-amplified metastatic NSCLC patients.
Trial Registration:
Chinese Clinical Trial Registry Identifier: ChiCTR1900021684 .
Insights
Pyrotinib plus apatinib shows significant promise for HER2-mutated non-small cell lung cancer (NSCLC). This combination therapy achieved a high objective response rate and demonstrated a manageable safety profile in patients previously treated for metastatic NSCLC.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Non-small cell lung cancer (NSCLC) with HER2 alterations remains challenging to treat.
- Existing targeted therapies for HER2-mutated NSCLC have not fully met patient needs.
- The PATHER2 trial investigated novel therapeutic strategies for this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of pyrotinib combined with apatinib.
- To assess the objective response rate (ORR) in previously treated HER2-altered metastatic NSCLC patients.
- To determine the progression-free survival (PFS) and overall survival (OS) for this combination therapy.
Main Methods:
- Phase 2 clinical trial design (PATHER2).
- Treatment regimen: oral pyrotinib (400 mg) plus apatinib (250 mg) daily until disease progression or toxicity.
- Patient population: previously treated metastatic NSCLC with HER2 mutations or amplification.
Main Results:
- Investigator-assessed ORR was 51.5% (17/33).
- Disease control rate reached 93.9% (31/33).
- Median PFS was 6.9 months and median OS was 14.8 months, with manageable side effects like diarrhea and hypertension.
Conclusions:
- Pyrotinib plus apatinib exhibits significant antitumor activity in HER2-mutated/amplified metastatic NSCLC.
- The combination therapy presents a promising and tolerable treatment option for patients with unmet therapeutic needs.
- This regimen warrants further investigation in HER2-altered NSCLC.
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