Osaka, Japan & Cambridge, Mass., United States:
- Mobocertinib, an oral targeted therapy, demonstrated clinically meaningful responses, with a confirmed objective response rate of 35% as assessed by investigator and 28% as assessed by an independent review committee (IRC)
- Responses shown with mobocertinib were durable, with a median duration of response of 17.5 months as assessed by IRC
- Results represent encouraging progress in a patient population for which no approved targeted therapies exist
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced new data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in previously treated patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) will be presented as a late-breaking oral session at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) on Friday, January 29 SGT.
“Results show mobocertinib demonstrated clinically meaningful responses and a noteworthy duration of response in patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum-based therapy,” said Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute. “These data are promising and provide further evidence for mobocertinib as a potential oral treatment for patients with EGFR Exon20 insertion+ mNSCLC, who are in critical need of targeted treatment options.”
The analysis of platinum-pretreated patients included patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum therapy from the Phase 1/2 trial. All patients were treated at the 160 mg once daily oral dose. Key findings from this population include:
| Parameter | Results in Platinum-Pretreated Population (N=114) |
| Confirmed objective response rate (ORR) per investigator | 35% (40/114; 95% CI 26-45) |
| Confirmed ORR per IRC | 28% (32/114; 95% CI 20-37) |
| Median duration of response (DoR) per IRC | 17.5 months (95% CI 7.4-20.3) |
| Median progression-free survival (PFS) per IRC | 7.3 months (95% CI 5.5-9.2) |
| Disease control rate (DCR) per IRC | 78% (89/114; 95% CI 69-85) |
The safety profile observed was manageable. The most common treatment-related adverse events (TRAEs; ≥ 20%) in platinum-pretreated patients from the May data cutoff were diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), decreased appetite (32%), dry skin (30%) and vomiting (30%). Grade ≥3 TRAEs (≥5%) included diarrhea (21%). Nineteen patients (17%) discontinued due to AEs, most commonly diarrhea (4%) and nausea (4%). The safety profile from the November data cutoff was consistent with that of the May data cutoff.
“The importance of advancing research for people living with EGFR Exon20 insertion+ mNSCLC – a complex and devastating disease with no approved targeted therapies – cannot be overstated, as existing treatment options provide limited benefit and patients often have poor survival outcomes,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “We’re proud of these positive results from mobocertinib, the first oral therapy designed to selectively target their disease, and we look forward to submitting data from the platinum-pretreated population analysis to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the globe.”
Mobocertinib is currently not approved for EGFR Exon20 insertion+ mNSCLC.
Takeda will host a briefing for analysts and investors on Friday, January 29, at 5:00 p.m. ET to discuss these data and the mobocertinib program.Please contact [email protected] for further details. Presentation slides and an archived replay of the webcast will be available at https://www.takeda.com/investors/reports/ir-events/.
About the Phase 1/2 Trial
The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). The trial is comprised of a Phase 1 dose-escalation, evaluating mobocertinib as a monotherapy and in combination with chemotherapy, and a Phase 2 expansion, which includes seven different cohorts, as well as an extension cohort, investigating the anti-tumor activity of mobocertinib in various trial populations.
The platinum-pretreated population analysis investigated 114 patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) who received prior platinum-based therapy from the escalation and expansion phases of the Phase 1/2 trial and were treated with mobocertinib at the 160 mg once daily dose.
The Phase 2 extension cohort, known as EXCLAIM, investigated 96 previously treated patients with EGFR Exon20 insertion+ mNSCLC who were treated with mobocertinib at the 160 mg once daily dose.
About Mobocertinib (TAK-788)
Mobocertinib, an oral therapy, is a potent, small-molecule tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with human EGFR 2 (HER2) mutations or EGFR mutations including Exon20 insertion mutations. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. In October 2020, mobocertinib was designated as a Breakthrough Therapy in China by the Drug Review Center (CDE) for the same indication.
About EGFR Exon20 Insertion+ mNSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations because there are currently no FDA-approved therapies that target Exon20 insertions, and current EGFR TKIs and chemotherapy provide limited benefit for these patients.
Takeda is committed to continuing research and development in EGFR Exon20 insertion+ mNSCLC with the hope of introducing a targeted treatment option for the approximately 30,000 patients diagnosed with the disease worldwide each year.3,4
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.
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