- FDA Approves Expanded Injectable Treatment Formula for Smallpox-Monkeypox
- UK and Netherlands follow Belgium to implement “monkeypox quarantine”
- European EMA removes about 100 generic drugs
- EU approves AstraZeneca’s COVID-19 vaccine as booster shot
- First injection of cancer-killing oncolytic virus into human patient
- First monkeypox quarantine order: Belgium requires to self-isolate for 21 days
New therapies and new drugs for lung cancer
New therapies and new drugs for lung cancer. Lung cancer is a high-incidence cancer in the world, and its treatment methods are constantly innovating.
In 2020, we have witnessed many critical moments: the first dual immunotherapy was approved, TMB was approved for the first time as a biomarker, China’s first PD-1 monoclonal antibody was approved for lung cancer indications, etc.
Recently, what new drugs and new therapies have made breakthroughs in the treatment of lung cancer?
▌FDA approved the first targeted adjuvant therapy
On December 19, 2020, the FDA approved osimertinib for postoperative adjuvant treatment of non-small cell lung cancer with sensitive EGFR mutations based on the results of the ADAURA study. This is the first targeted adjuvant therapy approved by the FDA, which means that more patients with non-small cell lung cancer will be able to use targeted therapy at an earlier time.
According to good doctors, surgery is the main treatment method for early stage non-small cell lung cancer, and about 1/3 of patients can be treated with surgery at the time of diagnosis. For some patients with stage IB and stage II~IIIA non-small cell lung cancer, the postoperative adjuvant chemotherapy reduces the mortality rate by only about 5%, and the disease recurrence is still very high. The 5-year recurrence rate is about 40% to 70%.
The ADADURA study is a randomized, double-blind, placebo-controlled phase III study. 682 patients (with or without adjuvant chemotherapy) were randomly assigned to receive osimertinib treatment or standard adjuvant chemotherapy + placebo treatment. The results showed that compared with placebo, osimertinib significantly prolonged the median disease-free survival of patients with stage II to IIIA, and reduced the risk of disease recurrence or death by 83%.
▌The overall survival of carrelizumab combined with chemotherapy exceeds the 2-year mark
On December 19, 2020, “The Lancet-Respiratory Medicine” published online the interim analysis results of the phase III trial of carrelizumab combined with chemotherapy in the first-line treatment of patients with advanced non-squamous non-small cell lung cancer, showing progression-free survival And overall survival benefit.
The CameL study is a randomized, open-label, multi-center, phase III clinical trial. It included 412 patients with non-squamous non-small cell lung cancer without EGFR/ALK mutations and who had not received systemic chemotherapy before. Relilizumab combined with carboplatin+pemetrexed (n=205), and carrelizumab plus pemetrexed maintenance treatment; or only carboplatin+pemetrexed (n=207 ), and only use pemetrexed for maintenance treatment.
The results showed that the progression-free survival of the carrelizumab combined with chemotherapy was significantly longer (median 11.3 months vs 8.3 months), and the risk of progression or death was significantly reduced by 40%. Carrelizumab combined with chemotherapy also brought an overall survival (OS) advantage (median OS did not reach vs20.9 months), and the risk of death was reduced by 27%. Additional analysis suggests that carrelizumab combined with chemotherapy may extend the median OS to 27.9 months, compared with 20.5 months in the chemotherapy group.
▌The gospel of KRAS mutation, AMG510 was granted breakthrough therapy designation
On December 8, 2020, the FDA granted Sotorasib (AMG510) breakthrough therapy designation for the treatment of locally advanced or metastatic non-small cell lung cancer patients with KRASG12C mutation who have received at least one systemic treatment in the past.
KRAS is one of the most common oncogenes, but no targeted therapy for this gene has been approved. The emergence of KRAS G12C inhibitors broke the curse of this “unable to drug” target. AMG 510 is the first KRAS G12C inhibitor to enter the clinic and is expected to be the first to be approved.
▌ROS1 mutant new drug was recognized as a breakthrough therapy
On December 8, 2020, the FDA also granted Repotrectinib (TPX-0005) breakthrough therapy designation for ROS1 fusion-positive metastatic non-small cell lung cancer patients who have not been treated with ROS1 targeted drugs.
TPX-0005 is a small molecule tyrosine kinase inhibitor of the second generation of ROS1/TRK/ALK, and a new generation of broad-spectrum anticancer drugs.
The latest interim data of the second phase of phase II study TRIDENT-1 as of July 10, 2020, the results show:
- For newly treated patients with ROS1-positive non-small cell lung cancer, the objective remission rate reached 86%;
- For non-small cell lung cancer patients who have undergone TKI and chemotherapy, the objective remission rate reached 40%;
- ROS1-positive non-small cell lung cancer patients who have undergone TKI but have not received chemotherapy have an objective response rate of 67%;
- Patients with advanced solid tumors treated with NTRK-positive TKI have an objective remission rate of 50%.
(source:internet, reference only)