In the first half of the year, new drugs with outstanding efficacy continued to be approved for marketing.
For lung cancer, China’s National Drug Administration (NMPA) approved the new drug daclatinib for marketing and expanded the indication for pablizumab. During the same period, the US Food and Drug Administration (FDA) also expanded the indications for 2 immunologic agents.
Table New lung cancer drugs approved by the US FDA and our NMPA
| Type | Drug name | Indications | |
| United States | Immunization drugs | Pabrolizumab |
|
| atezolizumab | Combination chemotherapy (carboplatin + etoposide) for first-line treatment of extensive-stage small cell lung cancer | ||
| China | Targeted drugs | Dacitinib | First-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR mutation |
| Immunologics | Pabrolizumab | combination chemotherapy (pemetrexed and platinum) in first line for non-squamous non-small cell lung cancer without EGFR or ALK mutations |
Below, we describe the application of these new drugs and new indications.
Non-small cell lung cancer: the earlier PD-1 monoclonal antibody is used in patients without mutations, the greater the survival benefit may be
Non-small-cell lung cancer with EGFR mutations
More than 80% of lung cancer patients have non-small cell lung cancer (NSCLC). EGFR (epidermal growth factor receptor) mutations are the most common class of mutations in NSCLC patients, especially in Asian patients. For patients with advanced disease carrying such mutations, EGFR-targeted drugs – known professionally as EGFR tyrosine kinase inhibitors (TKI) – are more effective, less toxic, and have a better safety profile than chemotherapy.
Dacitinib, a new drug launched in China this year, is a second-generation EGFR TKI that has led to a median progression-free survival (PFS) of 14.7 months and an overall survival (OS) of 34.1 months in clinical trials, the best results among all currently available first- and second-generation EGFR TKI studies and the only EGFR TKI proven to achieve clinically meaningful OS improvement TKI, and therefore approved for first-line treatment.
Non-small cell lung cancer without EGFR, ALK mutations
Pabrolizumab was previously approved as first-line therapy for advanced NSCLC with PD-L1 expression ≥1%. This year, the FDA expanded the indication for pabrolizumab.
For patients with stage III NSCLC who are not candidates for surgery or concurrent radiotherapy, in the absence of EGFR or ALK mutations and with PD-L1 expression ≥1%, the median OS of pabrolizumab treatment was significantly better than chemotherapy (16.7 vs 12.1 months). For patients with PD-L1 ≥50%, pabrolizumab was the most effective, with a median OS of 20.0 months.
Our country also expanded the indication for pablizumab this year, recommending pablizumab in combination with standard chemotherapy as a first-line regimen for advanced nonsquamous NSCLC without EGFR or ALK mutations. This approval is based on the results of a clinical trial published in the New England Journal of Medicine. In the trial, pabrolizumab in combination with chemotherapy reduced the relative risk of patient death by half compared to chemotherapy alone. This also means that for patients with NSCLC, the earlier PD-1 monoclonal antibody is used, the greater the survival benefit is likely to be.
Small cell lung cancer: atezolizumab + chemotherapy emerges as the best first-line treatment option for patients with extensive disease
Patients who have failed multiple chemotherapies may be offered pablizumab
Small cell lung cancer (SCLC) accounts for 10% to 15% of lung cancers, is highly malignant, and is mostly advanced at diagnosis. Chemotherapy is routinely used, but it is prone to drug resistance and has a high recurrence rate. Treatment options are limited for this group of patients with refractory relapses. Last year, for SCLC that failed chemotherapy, the FDA approved treatment with the PD-1 monoclonal antibody, nabumetinumab.
This year, another PD-1 monoclonal antibody, pabrolizumab, was also approved by the FDA for the treatment of SCLC. in the study, the objective remission rate (ORR) for pabrolizumab treatment was 19% in patients who had failed multiple chemotherapy regimens. Previously, in similar patients, the ORR for nabolutumab was around 15%. With the expansion of the indication for pablizumab, there are more options for patients with clinically refractory SCLC.
Patients with initial diagnosis of extensive stage have the best first-line option
For patients with initial diagnosis of extensive-stage SCLC (ie, patients with advanced disease) and no prior therapy, atezolizumab in combination with chemotherapy (carboplatin + etoposide) as first-line therapy is expected to give patients a survival time of more than 1 year (12.3 months), significantly better than 10.3 months with chemotherapy.
For extensive-stage SCLC, this is the first time in nearly 30 years that a new first-line regimen has delivered an overall survival benefit and the first time that overall patient survival has been extended to more than 1 year. With FDA approval, atezolizumab in combination with chemotherapy has also emerged as the best option for first-line treatment of extensive-stage SCLC.