TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. kondigt aan dat de resultaten van het Japanse derdefaseonderzoek J-ALEX naar Alecensa® tegen ALK-fusiegenen-positieve niet-kleincellige longkanker (NSCLC) worden gepresenteerd op de jaarlijkse bijeenkomst van de American Society of Clinical Oncology (ASCO), die van 3 tot 7 juni plaatsheeft in Chicago. De mondelinge sessie over J-ALEX staat gepland op 6 juni (CDT).
J-ALEX is een gerandomiseerd open-labelonderzoek dat de effectiviteit en veiligheid van Alecensa vergelijkt met die van crizotinib. Aan J-ALEX namen 207 patiënten deel. Ze lijden aan ALK-fusiegenen-positieve NSCLC en zijn niet vatbaar zijn voor ALK-inhibitoren. De groep bestond uit patiënten die wel chemotherapie hebben gekregen en patiënten die geen chemotherapie hebben gekregen. De patiënten werden gelijkmatig onderverdeeld in een groep die Alecensa kreeg en een groep die crizotinib kreeg. Het primaire eindpunt van J-ALEX was progressievrije overleving, als zodanig vastgesteld door een onafhankelijke raad. De secundaire eindpunten waren onder meer algehele overleving, een objectief responscijfer en veiligheid.
Chugai to Present Japanese Phase III Results on Alecensa® at ASCO
TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the results of the Japanese phase III study (J-ALEX) of Alecensa ®, in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) which will be held June 3 -7 in Chicago, IL (USA). Results from the J-ALEX study will be presented at the oral abstract sessions scheduled for June 6 (CDT).
The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to either the Alecensa arm or the crizotinib arm of the study in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety, and other endpoints.
The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 and Alecensa demonstrated significantly prolonged PFS (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (36%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (59%), visual disturbance (55%), dysgeusia (52%), constipation (46%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 27% of the Alecensa arm and in 51% of the crizotinib arm, there were no treatment-related deaths in either arm.
In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the J-ALEX study.
“It was found in Japan earlier than in any other country in the world that ALK fusion gene serves as a powerful carcinogenic factor for some types of lung cancer. Alecensa was created by Chugai as a drug selectively inhibiting the activity of ALK fusion gene, and it was first approved in Japan in 2014 based on the Japanese clinical study data. The J-ALEX study, comparing Alecensa therapy directly with standard therapy, demonstrated superiority of Alecensa over standard therapy for the first time in the world. This finding not only greatly encourages the patients suffering from ALK fusion gene positive NSCLC but also illustrates the high level of drug development progression from basic research to clinical studies in Japan,” said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. “Chugai is extremely proud of having developed Alecensa which has been shown to provide benefit to patients.”
As a top pharmaceutical company in the field of oncology in Japan, Chugai believes that early treatment using Alecensa in ALK fusion gene positive NSCLC is expected to prolong these patients’ PFS and enable them to face their disease with hope for the future.
In Japan, Alecensa is available to patients with “ ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. In the US, Alecensa was approved in December 2015 for the indication of “anaplastic lymphoma kinase (ALK) positive, metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or those who are intolerant to crizotinib.” In September 2015, Roche filed the MAA in Europe to the European Medicines Agency for the approval of “ ALK fusion gene positive unresectable, recurrent/advanced NSCLC.”
1) Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients