Investigational Drug Information for TAK-788

What is the development status for investigational drug TAK-788?

TAK-788 is an investigational drug.

There have been 11 clinical trials for TAK-788. The most recent clinical trial was a Phase 1 trial, which was initiated on January 6^th 2020.

The most common disease conditions in clinical trials are Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, and Liver Diseases. The leading clinical trial sponsors are Millennium Pharmaceuticals, Inc., Takeda, and Ariad Pharmaceuticals.

There are twenty-two US patents protecting this investigational drug and two hundred and seventy-six international patents.

Summary for TAK-788

US Patents	22
International Patents	276
US Patent Applications	159
WIPO Patent Applications	211
Japanese Patent Applications	75
Clinical Trial Progress	Phase 1 (2020-01-06)
Vendors	52

Recent Clinical Trials for TAK-788

Title	Sponsor	Phase
A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788	Takeda	Phase 2
A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants	Takeda	Phase 1
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys	Millennium Pharmaceuticals, Inc.	Phase 1

See all TAK-788 clinical trials

Clinical Trial Summary for TAK-788

Top disease conditions for TAK-788

Top clinical trial sponsors for TAK-788

See all TAK-788 clinical trials

US Patents for TAK-788

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
TAK-788		Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors	Array BioPharma Inc. (Boulder, CO)
TAK-788		Heteroaryl compounds for kinase inhibition	ARIAD PHARMACEUTICALS, INC. (Cambridge, MA)
TAK-788		Dopamine D2 receptor ligands	The Broad Institute, Inc. (Cambridge, MA) Massachusetts Institute of Technology (Cambridge, MA)
TAK-788		Macrocylic compounds as ROS1 kinase inhibitors	Array BioPharma Inc. (Boulder, CO)
TAK-788		Dopamine D2 receptor ligands	The Broad Institute, Inc. (Cambridge, MA) Massachusetts Institute of Technology (Cambridge, MA)
TAK-788		Methods of treating B-cell proliferative disorder	Beigene Switzerland GmbH
TAK-788		Methods of treating B-cell proliferative disorder	Beigene Switzerland GmbH

International Patents for TAK-788

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
TAK-788	Australia	AU2016291676	2035-07-16
TAK-788	Brazil	BR112018000808	2035-07-16
TAK-788	Canada	CA2992586	2035-07-16
TAK-788	Chile	CL2018000119	2035-07-16
TAK-788	China	CN108349969	2035-07-16
TAK-788	Denmark	DK3322706	2035-07-16
TAK-788	Eurasian Patent Organization	EA035049	2035-07-16

Development Update and Market Projection for TAK-788 (Mobocertinib)

Last updated: January 1, 2025

Introduction to TAK-788 (Mobocertinib)

TAK-788, also known as mobocertinib, is a targeted therapy developed by Takeda Pharmaceuticals specifically designed to treat non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations. Here’s a detailed update on its development and market projections.

Clinical Trial Overview

The clinical development of TAK-788 involves several phases, each with distinct objectives:

Phase 1/2 Trials

• The initial trials focused on determining the safety, tolerability, and efficacy of TAK-788. These studies included assessing the recommended Phase 2 dose (RP2D), dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of TAK-788[1].
• Notably, a phase 1/2 trial (NCT02716116) showed promising results, with TAK-788 inducing a confirmed objective response rate (ORR) of 28% and a median duration of response (DOR) of 17.5 months in patients with EGFR Exon 20 insertion mutations[3].

Phase III Trials

• The Phase III EXCLAIM 2 study was initiated to evaluate TAK-788 as a first-line treatment for NSCLC patients with EGFR Exon 20 insertion mutations. However, this study was put on hold for a futility analysis to ensure the most promising approach was being advanced[2].

Regulatory Status

FDA Approvals and Designations

• TAK-788 received accelerated approval from the U.S. FDA for the treatment of adult patients with EGFR Exon 20 insertion mutation-positive metastatic NSCLC who have received prior platinum-based chemotherapy. This approval was based on findings from a cohort of patients in a phase 1/2 trial[3].
• The FDA granted priority review for the New Drug Application (NDA) for TAK-788, with a Prescription Drug User Fee Act (PDUFA) target action date set for October 26, 2021[5].

Safety and Efficacy

Primary Outcome Measures

• The primary outcome measures in the clinical trials included the confirmed ORR assessed by the investigator and the independent review committee (IRC), as well as the intracranial ORR (iORR) for patients with brain metastases[1].

Secondary Outcome Measures

• Secondary measures focused on the pharmacokinetics of TAK-788, including maximum observed concentration (Cmax), time of first occurrence of maximum plasma concentration (Tmax), and area under the concentration-time curve (AUC)[1].

Market Projections

Revenue Potential

• Takeda anticipates peak revenue potential for mobocertinib to be in the range of $300 million to $600 million in both the first-line (1L) and second-line (2L) settings for EGFR Exon 20 insertion mutation NSCLC[2].

Competitive Landscape

• The EGFR-NSCLC treatment market is highly competitive, with other agents like amivantamab from Janssen Pharmaceutical Companies showing higher ORR and safety profiles in some studies. However, TAK-788 remains a significant player due to its specific targeting of EGFR Exon 20 insertion mutations[2][4].

Market Dynamics

• The EGFR-NSCLC treatment market is evolving rapidly, with novel generation EGFR and ALK inhibitors in advanced clinical development. TAK-788, along with other emerging therapies, is expected to contribute significantly to this market, although TAGRISSO (osimertinib) is likely to remain a standard of care[4].

Challenges and Future Directions

Futility Analysis and Study Hold

• The Phase III EXCLAIM 2 study was put on hold due to a futility analysis, which may impact the timeline and outcomes of the study. This decision is crucial in determining whether the study will continue and how it will affect the drug's market prospects[2].

Voluntary Withdrawal

• In a recent development, Takeda announced the voluntary withdrawal of mobocertinib for EGFR Exon 20 insertion NSCLC, citing the need for further evaluation and potential adjustments in the treatment strategy[3].

Key Takeaways

• Targeted Therapy: TAK-788 is specifically designed to target EGFR Exon 20 insertion mutations in NSCLC.
• Clinical Trials: The drug has shown promising results in phase 1/2 trials but faces challenges in Phase III due to a futility analysis.
• Regulatory Status: TAK-788 received accelerated FDA approval and priority review but has been voluntarily withdrawn for further evaluation.
• Market Potential: Despite competition, TAK-788 has significant revenue potential in the EGFR-NSCLC market.
• Future Directions: The drug's future depends on the outcomes of ongoing evaluations and potential adjustments in clinical strategies.

FAQs

What is TAK-788 (mobocertinib), and what is it used for?

TAK-788, or mobocertinib, is a targeted therapy designed to treat non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations.

What are the key findings from the clinical trials of TAK-788?

Clinical trials have shown a confirmed ORR of 28% and a median duration of response of 17.5 months in patients with EGFR Exon 20 insertion mutations[3].

Why was the Phase III EXCLAIM 2 study put on hold?

The Phase III EXCLAIM 2 study was put on hold for a futility analysis to ensure the most promising approach was being advanced for patients who could benefit from first-line mobocertinib[2].

What is the current regulatory status of TAK-788?

TAK-788 received accelerated FDA approval but has been voluntarily withdrawn for further evaluation and potential adjustments in the treatment strategy[3].

What is the projected revenue potential for TAK-788?

Takeda anticipates peak revenue potential for mobocertinib to be in the range of $300 million to $600 million in both the first-line and second-line settings for EGFR Exon 20 insertion mutation NSCLC[2].

How does TAK-788 compare to other treatments in the EGFR-NSCLC market?

TAK-788 faces competition from other agents like amivantamab but remains a significant player due to its specific targeting of EGFR Exon 20 insertion mutations[2][4].

Sources

1. ClinicalTrials.takeda: A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer.
2. ClinicalTrialsArena: Takeda's Phase III mobocertinib study in 1L NSCLC on enrolment pause for futility analysis.
3. Onclive: Takeda to Voluntarily Withdraw Mobocertinib for EGFR Exon 20 Insertion NSCLC.
4. DelveInsight: Evolving Treatment Market Dynamics of EGFR-NSCLC | Key Insights.
5. Takeda Oncology: Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788).