ArriVent's furmonertinib builds bridge with Chinese partner Allist in NSCLC | $AVBP

SUMMARY

If only geopolitical tensions between China and the US could thaw as well as the dynamic between the FDA and Chinese pharmaceutical companies. Two years ago, the FDA’s Richard Pazdur infamously reversed his view about accepting China-only cancer trial data as a basis for US regulatory approval. In late 2023, the FDA greenlighted clinical trials from ArriVent BioPharma, Inc. (NASDAQ:AVBP) of furmonertinib, a drug advanced and marketed in China by Shanghai Allist Pharmaceuticals (Allist), ArriVent’s partner in China. Founded in 2021, ArriVent licensed the global rights to furmonertinib, excluding China, during the same year. ArriVent listed on the NASDAQ in January 2024.

ArriVent and Allist are jointly conducting phase III (FURVENT) and phase Ib trials (FURTHER) of furmonertinib to treat non-small cell lung cancer (NSCLC) patients. Another phase Ib trial (FAVOUR) is being managed in China by Allist. The partners contend furmonertinib, marketed in China as a first-line therapy to treat classical epidermal growth factor receptor mutation (EGFRm) NSCLC, can address a broader set of EGFRms than currently approved tyrosine kinase inhibitors (TKIs), such as AstraZeneca plc’s (NASDAQ: AZN) third-generation EGFR TKI osimertinib (TAGRISSO).

Next Key catalysts

• Data from global, phase Ib FURTHER trial testing furmonertinib in non-small cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor mutations (EGFRms), including PACC mutations

• Data from phase Ib FAVOUR trial testing furmonertinib in locally advanced or metastatic NSCLC patients who have EGFR exon 20 insertion mutations

Key catalyst dates

• 2H 2024

Sentiment, MACE Score & The Edge….

SanaCurrents assigns a 73% overall probability ArriVent will report positive data for the phase Ib FURTHER and FAVOUR trials.

The FAVOUR trial is testing furmonertinib in locally advanced or metastatic NSCLC patients who have EGFR exon 20 insertion mutations. Furmonertinib is approved in China as a first-line therapy to treat classical EGFRm NSCLC. The FAVOUR trial zeroes in on EGFRm patients with the well-characterized exon 20 insertion mutations. In an interim readout of the FAVOUR trial in first-line EGFRm NSCLC patients with exon 20 insertion mutations, 79% of (22 out of a sample size of 28 patients) were observed to experience a reduction in tumor size of at least 30% from baseline. In the same interim readout, those 79% of patients experienced a 15.2-month median duration of response (DOR). The primary endpoint in the FAVOUR trial is the overall response rate. Enrollment in the FURTHER trial is complete. ArriVent and Allist expect to present final data results of the trial before the end of 2024.

The 175 subjects in the FURTHER trial will include NSCLC patients with epidermal growth factor receptor mutations (EGFRms) and also patients with exon 20 insertions or P-loop and-alpha-c-helix compressing (PACC) mutations. Both exon 20 and PACC mutations are further subtypes of the uncommon EGFR mutation. According to ArriVent, furmonertinib demonstrated pre-clinical activity against PACC mutations in early studies. Data from the proof-of-concept FURTHER trial is expected before the end of the year.

THE EDGE

Not only did the FDA approve the clinical trials for furmonertinib last year, the agency also granted breakthrough designation for the drug in October 2023. Awarding breakthrough designation for a drug at the phase I or phase II level, or when the drug is approved in another country, is very rare. The furmonertinib data and patient results, however, must have been compelling, even if the drug was only administered as “approved” in China. The FDA likely concluded furmonertinib legitimately would be a “breakthrough” for a poorly treated cancer population. The agency also signed off on the globally conducted, phase III FURVENT trial.

The FURVENT trial will be in treatment naive, or first-line, patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations. Data from the 375-patient, open label trial are not expected until 2025. If ArriVent can combine the data from the three trials successfully, it may be able to present a compelling case for furmonertinib approval in early 2026.

Biotech chatter early this year prattled on how IPO investors were favoring companies with late-stage drug candidates. If true, ArriVent meets the standard, as does another oncology company that listed, CG Oncology, Inc. (NASDAQ:CGON). ArriVent, however, already has a drug for a rare cancer indication that already is working in patients. All ArriVent needs to do is maintain the data through the phase Ib trials, and then subsequently in a confirmatory phase III trial. Maybe too many “ifs,” but the odds favor ArriVent as the clinical trial process already has been established through its Allist alliance.

ArriVent will not have the imprimatur of a significant Big Pharma alliance, as secured by many earlier Chinese pharmaceutical companies such as Hutchmed Limited (NASDAQ:HCM). That’s why the shares of Pennsylvania-based ArriVent, provided it succeeds with its clinical trials, should be able to deliver hefty returns over the next two years.

Disclosure:

1. SanaCurrents, the parent of BioCurrents, is initiating coverage and a position in AVBP. SanaCurrents may close its position in AVBP prior to or following the expected catalyst date.