Better than Xalkori! Beida Pharmaceuticals ALK inhibitor NSCLC Phase III clinical reached the main endpoint.

Recently, Beta Pharmaceuticals Holdings, a subsidiary of Beida Pharmaceuticals, presented its new generation of ALK inhibitor ensartinib, X-396 and the equivalent drug Pfizer Xalkorib (Crezotinib) comparison of the international multi-center phase 3 clinical study (eXalt3) at the IASLC WCLC Bureau seminar.
results showed that the median progression-free survival (mPFS) in patients treated with Ensatinib for ALK-positive non-small cell lung cancer (NSCLC) was significantly longer than in patients treated with cratinib and reached the primary endpoint.
it is known that a total of 290 ALK-positive NSCLC patients in the eXalt3 study were randomly assigned to the ensatinib or krysatinib treatment group.
data as of July 1 this year, progress events accounted for 73% of the final analysis of pre-set progress events, as assessed by the Blind Independent Review Board (BIRC).
data showed that the mPFS was 25.8 months in the patients with Ensatinib and 12.7 months in the gramatinib group, with significant statistical differences between the two.
Survival Analysis (K-M Curve) showed that at 36 months after treatment, less than 40 percent of patients in the Ensatinib group showed progress, while 75 percent of patients in the Krzysconomine group progressed.
, Ensatinib reduced the tumor of 75 percent of untreated lung cancer patients, more than 67 percent of the cancer rate, and delayed the onset of cancer for about two years, more than twice as many as the gramibini.
currently, the eXalt3 study will continue to follow up on patients being treated.
in a small number of alK-positive NSCLC patients whose disease has spread to the brain, Ensatinib also showed better therapeutic results.
in the Enshatinib treatment group, all 11 cases of brain tumors were larger and the tumors of patients with clear visible lesions during the scan scans were reduced.
seven (64%) of the patients with brain tumora atrophy were considered to be responsive.
, only 1/5 of the 19 patients in the keratosini treatment group responded.
safety, the most common side effect senile found in the study was a sunburn-like rash, a "new toxicity" of ALK inhibitors.
in addition, about 40 patients were recruited for ALK mutation testing in local laboratories, and then centralized testing of incoming patients in large laboratories.
this is done to reduce false positive results from local testing agencies.
it is understood that of the 43 patients tested in local laboratories, 11 were falsely positive for ALK, 7 were treated with Ensatinib and 2 were treated with cratinib.
because Ensatinib is only targeted at ALK protein, if the patient is ALK negative, it is impossible to slow tumor growth.
understandable, false-positive patients distort the data, so the researchers also reported results in what they called "improved intentional treatment in a population that only received centralized testing."
PFS in this group of patients had not yet been met by the data cut-off, meaning that more than half of the patients had not had a cancer worsenby by then.
this figure was 12.7 months in patients treated with keratosin.
transsexual lymphoma kinase (ALK) is one of the important cancer-causing drivers of NSCLC, according to statistics, the ALK fusion protein gene in this part of the positive rate of about 5%, and most of them in young, non-smoking or mild smoking lung adenocarcinoma patients.
alK activation can lead to the activation of downstream signaling pathways, which can lead to tumor occurrence and survival, and ALK inhibitors can effectively inhibit the activity of ALK, thereby inhibiting tumor growth.
and keratinib is the first FDA-approved drug to target alK, the first generation of ALK inhibitors.
Enshatini is a new, powerful, highly selective new generation OF ALK inhibitor developed by Beida Pharmaceuticals and its controlling subsidiary Xcovery with fully independent intellectual property rights.
the drug has a strong binding force with ALK, and the results of the analysis of efficacy, safety and biomarkers in patients with ALK mutation-positive NSCLC after the failure of ensatinib treatment with cratinib treatment showed that the objective remission rate (ORR) was 52%, the disease control rate (DCR) was 93%, and the intracranial R and DCR were 70% and 98%, respectively.
Enshatinib's role (source: corporate website) The next step, based on the eXalt3 study, Xcoverwill will discuss data with drug regulators and actively prepare Ensatinib in China and the United States as the first-line treatment of ALK-positive NSCLC, which may become the first Chinese-led global lying lung cancer target ingress.
if Ensatinib is approved, there will be more competition in the same field, in addition to Xalkori, which also includes Roche's Alecensa and Zykadia, which have surpassed Xalkori in 2017 for applications for first-line therapeutic indications, which is currently the drug's sales leader; and Pfizer's Lorinabre, which is the current sales leader. Xalkori's third-generation ALK inhibitors also released the latest results earlier, which are expected to beat Xalkori and regain a place in the field.
Source: 1, WCLC: Xcovery's Xalkori challenger in shines 3 lung cancer dandeman 2, company official website.