The past two years have seen a blossoming of the lung cancer treatment field, with new drugs launched mainly in the rapidly developing fields of targeted therapy and immunotherapy. 2018 saw the approval of four new lung cancer drugs in China – anlotinib, ceritinib, navulizumab and aletinib – with promising clinical efficacy, bringing hope to more and more lung cancer The promising clinical efficacy has brought hope and confidence to more and more lung cancer patients.
What other major new drugs will be available for lung cancer patients in China in the first half of 2019? The following four new lung cancer drugs are expected to be approved for marketing, and we are waiting for them together.
Evitinib: a domestic third-generation EGFR-targeting drug comparable to oxitinib
Lung cancer is the cancer with the highest incidence and mortality rate, about 85% of which is non-small cell lung cancer (NSCLC), and EGFR (epidermal growth factor receptor) mutations are the most common type of mutation in patients with NSCLC in China.
Evitinib, the first third-generation EGFR inhibitor developed independently in China, is an original new drug supported by the National 12th Five-Year Plan “Major New Drug Creation” Science and Technology Major Project.
- Clinical studies have found that ivitinib is highly selective and can irreversibly inhibit EGFR mutated genes in lung cancer with a selective advantage of nearly 300-fold, resulting in very few side effects;
- At the same time, the ability of ivitinib to overcome drug-resistant mutations provides an advantage comparable to that of oseltinib, the only third-generation EGFR-targeting agent currently available.
On June 25, 2018, the National Center for Drug Review accepted the marketing application for ivitinib maleate and included it in the priority review, and it is currently in the “under review and approval” stage, which is expected to be the first shot of a new targeted lung cancer drug to be launched in China soon.
Dacitinib: a tiger among second-generation EGFR-targeted drugs
Dacomitinib is a second-generation EGFR-targeted drug developed by Pfizer Inc. for the first-line treatment of patients with advanced NSCLC with EGFR mutations.
- Dacomitinib significantly prolongs patient survival compared to the classic generation EGFR-targeting agent gefitinib (ERSA) and is more effective in patients of Asian descent.
On September 28, 2018, the FDA approved daclatinib for the first-line treatment of patients with EGFR mutations in locally advanced, or metastatic, NSCLC. The company is expected to be approved for marketing in the first half of 2019.
Ensatinib: a solution for crizotinib resistance in ALK-targeted drugs
In addition to the most common EGFR mutation (~35%), ALK mutations are an important phenotype (~2%-5%) in NSCLC patients, mostly in young, nonsmoking or lightly smoking lung adenocarcinoma patients.
- Ensatinib (X-396), a highly selective second-generation ALK inhibitor, may be effective if crizotinib treatment in ALK mutation-positive patients with advanced NSCLC is followed by disease progression, intolerance, or resistance.
- In addition, enzatinib can also be used in the first-line treatment of ALK mutation-positive patients, and based on the results of previous phase I and II clinical studies, enzatinib first-line treatment resulted in an objective remission rate of 80% and a median progression-free survival of 26.2 months.
On December 27, 2018, the State Drug Administration has accepted the marketing application for enzatinib, which is expected to be the first domestic ALK-targeted drug to be marketed in the first half of 2019.
Durvalumab: expected to be the first approved PD-L1 antibody
For patients with NSCLC who do not carry both EGFR and ALK mutations, the new immunotherapy drug Durvalumab, like atezolizumab, belongs to the PD-L1 (programmed death receptor ligand-1) monoclonal antibody class.
- Durvalumab was confirmed to be the first PD-L1 monoclonal antibody to provide clinical benefit to patients with stage III NSCLC in a phase 3 clinical trial in 2014.
- The study showed that Durvalumab was effective in stopping cancer progression as maintenance therapy in stage III patients whose disease had not progressed after first-line radiotherapy, with a median progression-free survival of 16.8 months for patients compared with 5.6 months for those who did not take the drug.
Durvalumab was approved in the United States and Canada in February and May 2018, respectively, for the treatment of locally advanced (stage III) NSCLC that cannot be surgically resected.On December 26, 2018, the National Center for Drug Review hosted the marketing application for Durvalumab, which is expected to be the first PD-L1 monoclonal antibody to be marketed in China.