Pasi A. Jänne, MD, Ph.D. from Dana-Farber Cancer Institute discusses Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress.
For more information go to IASLC – WCLC 2020 –
https://wclc2020.iaslc.org/
Cambridge, MASS. & Osaka, JAPAN, 28 January 2021-Takeda Pharmaceutical Company Limited (TSE:4502/NYSE: TAK) (‘Takeda’) today announced that new evidence from the Phase 1/2 trial of orally administered mobocertinib (TAK-788) in previously treated epidermal growth factor receptor (EGFR) patients would be presented with Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) as late-breaking oral lung cancer (mNSCLC)
Patients with EGFR Exon20 insertion+ mNSCLC who obtained previous platinum therapy from the Phase 1/2 trial were included in the study of platinum-pretreated patients. Both patients were treated with an oral dose of 160 mg once a day. This population’s main findings include:
Parameter by Parameter
Platinum-Pretreated Population Findings (N=114)
Objective response rate (ORR) verified per investigator
35% (40/114; CI 26-45 95 percent)
ORR confirmed per IRC
(32/114; 95 percent CI 20-37) 28 percent
Median response length (DoR) per IRC
17.5 months Within 17.5 months (95 percent CI 7.4-20.3)
Median survival without progression (PFS) per IRC
7.3 months " 7.3 months (95 percent CI 5.5-9.2)
Per IRC, disease control levels (DCR)
78 percent (89/114; CI 69-85 95 percent)
The profile of protection observed was manageable. Diarrhea (90 percent), rash (45 percent), paronychia (34 percent), nausea (32 percent), reduced appetite (32 percent), dry skin (30 percent), and vomiting were the most common treatment-related adverse effects (TRAEs; ⇠20 percent) in platinum-pretreated Can data cutoff patients (30 percent ). Diarrhea was included in grade 3 TRAEs (~5 percent) (21 percent ). Nineteen patients (17%) were discontinued due to AEs, diarrhea (4%), and nausea, most commonly (4 percent ). The safety profile from the cutoff of November data was consistent with that of the cutoff of May data.
For EGFR Exon20 insertion+ mNSCLC, Mobocertinib is currently not approved.
On Friday, January 29, Takeda will hold a briefing for analysts and investors at 5:00 p.m. ET to discuss this data and the software for mobocertinib. For additional info, please contact TakedaRandDEvents@fticonsulting.com. Slides of the presentation and an archived webcast replay will be available at https://www.takeda.com/investors/reports/ir-events/.
About the Trial of Step 1/2
The Phase 1/2 trial aims to determine the efficacy, pharmacokinetics, and anti-tumor activity of oral mobocertinib in non-small cell lung cancer patients (NSCLC). The study consists of Phase 1 dose-escalation trial testing mobocertinib as monotherapy and in conjunction with chemotherapy, and a Phase 2 dose-escalation trial containing seven separate cohorts, as well as an extension cohort examining the anti-tumor efficacy of mobocertinib in different populations of the trial.
The platinum pretreated population study examined 114 patients with Exon20+ metastatic NSCLC (mNSCLC) epidermal growth factor receptor (EGFR) who obtained prior platinum-based therapy from the escalation and expansion process of the Phase 1/2 trial and were treated with mobocertinib once daily at a dose of 160 mg.
The Phase 2 extension cohort, known as EXCLAIM, examined 96 previously treated EGFR Exon20+ mNSCLC patients treated with mobocertinib once daily at a dose of 160 mg.