On March 4, 2022, the FDA approved navulilizumab plus platinum-containing dual-agent chemotherapy for neoadjuvant therapy in adult patients with excisable small cell lung cancer. This means that there is official official support for the use of navulilizumab plus chemotherapy in preoperative lung cancer patients.
What is neoadjuvant therapy?
In layman's terms, it is the treatment that is performed before surgery, and this concept was first introduced from breast cancer. Including neoadjuvant chemotherapy, neoadjuvant radiotherapy, neoadjuvant immunotherapy, neoadjuvant endocrine therapy and so on. The benefits of neoadjuvant therapy before cancer surgery are reflected in three points:
1. Larger tumors are reduced after treatment, which is more convenient for surgery, which is called clinical hypophasic in our technical term. For example, although 5cm lung cancer can be operated on, it is reduced to less than 3cm after neoadjuvant treatment, and the staging is different, from medium-term lung cancer to early lung cancer.
2. Can eliminate tiny metastases, as we all know, the reason why cancer is easy to recur metastasis after surgery, the biggest reason is that although the primary lesion is partially removed, but the cancer cells may have run to other places before surgery, but CT can not be found, we call it micrometases. After the operation, the immunity decreases, and the micro-metastatic cancer cells will wait for the opportunity to move and make a comeback, resulting in recurrent metastasis, and neoadjuvant therapy can eliminate these micro-metastases in advance.
3. Judge drug sensitivity Another advantage of neoadjuvant therapy is to verify whether the drug is sensitive before surgery, because at this time the tumor lesion exists, the comparison before and after treatment, whether it is effective, and how effective it is, at a glance. For sensitive drugs, they can be continued after surgery.
The indications for the approval of neoadjuvant therapy for lung cancer by navuliyumab (O drug) are based on the results of a Phase III clinical study called CheckMate-816. The main admission criteria for the trial were: histologically confirmed stage IB (≥4 cm), stage II or STAGE IIIA, ECOG physical status score of 0 or 1 and non-small cell lung cancer with measurable lesions (RECIST1.1).
358 patients were randomized to receive navulilizumab (360 mg) on the same day with platinum-containing dual-agent chemotherapy (one course every 3 weeks for a total of 3 courses) or platinum-containing dual-drug chemotherapy alone (one course every 3 weeks for a total of 3 courses) before surgery.
Results were assessed based on two core indicators—event-free survival (EFS) and pathological complete remission (pCR). Results showed that preoperative use of navulilizumab plus chemotherapy showed a statistically significant improvement in event-free survival (EFS) (31.6 months vs 20.8 months) and a 37% reduction in the risk of disease progression, recurrence or death in patients compared with chemotherapy alone. 24% of patients in the navulilizumab combined chemotherapy group achieved complete pathological remission, compared with only 2.2% of patients in the chemotherapy group alone.
Navulilimab is the first approved PD-1 inhibitor combined with platinum-containing chemotherapy for early resectable NSCLC neoadjuvant therapy without the need to look at PD-L1 expression. At present, in terms of neoadjuvant treatment, domestic users still need to use it at their own expense, and patients can choose according to their economic conditions.