Introduction to Merestinib
Merestinib, also known as LY2801653, is an experimental cancer drug developed by Eli Lilly. It is a small molecule inhibitor targeting the MET receptor tyrosine kinase, as well as several other kinases including MST1R, FLT3, AXL, MERTK, TEK, ROS1, NTRK1/2/3, and DDR1/2. This broad spectrum of inhibition makes merestinib a promising candidate for treating various types of cancers[5].
Current Development Status
Phase II Trials and Termination
A recent development in the merestinib pipeline involves the termination of an investigator-led Phase II trial in solid tumors. This trial, conducted by the Dana-Farber Cancer Institute, was halted due to funding issues. The termination led to a significant drop in the Phase Transition Success Rate (PTSR) for merestinib in solid tumors, from 26% to 11%[1].
Other Ongoing and Completed Trials
Despite the setback, merestinib has been evaluated in other clinical settings. For instance, a Phase I study combining merestinib with ramucirumab (an anti-VEGFR2 monoclonal antibody) showed promising results in patients with metastatic colorectal cancer (mCRC). The combination was found to be tolerable and may provide clinical benefit, with 52% of patients achieving stable disease and a median progression-free survival of 3.3 months[3].
Merestinib has also been part of Phase II clinical trials for advanced biliary tract cancer and non-small cell lung cancer, which were initiated in 2016. However, the status of these trials, especially the one for biliary tract cancer expected to complete in April 2018, is not up-to-date in recent reports[5].
Safety and Efficacy
Safety Profile
The safety profile of merestinib, particularly when combined with ramucirumab, has been generally well-tolerated. The Phase I study reported that the most common grade 3 or higher treatment-related adverse events included fatigue, increased blood alkaline phosphatase, diarrhea, and hypertension. One patient discontinued treatment due to cholestatic hepatitis, but overall, the combination did not show significant drug-drug interactions[3].
Efficacy Data
While the combination of merestinib and ramucirumab did not result in complete or partial responses, it did achieve stable disease in approximately 50% of the patients. This suggests potential clinical benefit, especially in heavily pretreated populations. The median overall survival was 8.9 months, indicating some level of efficacy in this patient group[3].
Market Projection
Oncology Drugs Market
The global oncology drugs market is experiencing rapid growth, driven by innovative treatments and increasing investments in cancer research. The market is projected to grow from $220.80 billion in 2024 to $518.25 billion by 2032, at a CAGR of 11.3%[4].
Targeted Therapy Segment
Merestinib, as a targeted therapy agent, falls within a segment that is expected to dominate the oncology drugs market. Targeted drugs, which minimize off-target side effects, are gaining preference due to their efficacy and safety profiles. The rising number of pipeline candidates and regulatory approvals for new cancer drugs will further fuel the growth of this segment[4].
Checkpoint Inhibitor Refractory Cancer Market
Although merestinib is not specifically a checkpoint inhibitor, the growth in the checkpoint inhibitor refractory cancer market is indicative of the broader trend in immunotherapy and targeted treatments. This market is projected to grow at a CAGR of 11.26% from 2023 to 2033, reaching $112.43 billion by 2033. This growth is driven by the increasing number of FDA approvals for checkpoint inhibitors and their expanding indications across various cancer types[2].
Key Takeaways
- Development Status: Merestinib's Phase II trial in solid tumors was terminated due to funding issues, but other trials, such as the combination with ramucirumab, show promise.
- Safety and Efficacy: The drug has a tolerable safety profile and potential clinical benefit, especially in combination therapies.
- Market Growth: The oncology drugs market, particularly the targeted therapy segment, is expected to grow significantly, providing a favorable environment for merestinib if it progresses successfully.
- Market Size: The global oncology drugs market is projected to reach $518.25 billion by 2032, with targeted therapies playing a dominant role.
FAQs
1. What is merestinib and how does it work?
Merestinib is an experimental cancer drug that inhibits the MET receptor tyrosine kinase and several other kinases, making it a targeted therapy for various cancers.
2. What was the outcome of the Phase II trial in solid tumors?
The Phase II trial in solid tumors was terminated due to funding issues, leading to a drop in the Phase Transition Success Rate (PTSR) for merestinib.
3. How safe is the combination of merestinib and ramucirumab?
The combination of merestinib and ramucirumab has been found to be generally well-tolerated, with common adverse events including fatigue, increased blood alkaline phosphatase, diarrhea, and hypertension.
4. What is the projected growth of the oncology drugs market?
The global oncology drugs market is projected to grow from $220.80 billion in 2024 to $518.25 billion by 2032, at a CAGR of 11.3%.
5. How does merestinib fit into the broader oncology market trends?
Merestinib, as a targeted therapy agent, aligns with the growing trend of targeted therapies in the oncology market, which are preferred for their efficacy and safety profiles.
Sources
- ClinicalTrialsArena: Pipeline Moves: Investigator-led trial of Lilly's merestinib in solid tumours terminated.
- Future Market Insights: Checkpoint Inhibitor Refractory Cancer Market Outlook - 2033.
- Oxford Academic: Phase I Study of Ramucirumab Plus Merestinib in Previously Treated Patients with Metastatic Colorectal Cancer.
- Fortune Business Insights: Oncology Drugs Market Size, Share & Growth | Statistics [2032].
- Wikipedia: Merestinib.