You Need to Know to Get the Full Effect... Companion Diagnostics, the Partner in Cancer Treatment

Yuhan's 'Reclaza' Effective Against Specific Variants
Panagen Companion Diagnostic Needed to Confirm Variants Before Treatment

Companion Diagnostics Expected to Grow for Genetic Diseases and Dementia

Whenever Yuhan Corporation's non-small cell lung cancer treatment 'Leclaza' (active ingredient Lazertinib), which has successfully expanded its indication as a first-line treatment, is mentioned, one term is invariably brought up: the 'epidermal growth factor receptor (EGFR)' mutation. This is because Leclaza is approved for lung cancer patients with EGFR mutations. Conversely, this means that patients without EGFR mutations do not respond to the drug.

Recently, new drugs targeting specific genetic mutations like Leclaza have been emerging one after another. To receive the proper therapeutic effect, it is necessary to diagnose whether the patient has the relevant mutation before administration. This is called 'companion diagnostics (CDx).' With the continuous introduction of anticancer drugs, the companion diagnostics market is also expected to grow.

According to the Ministry of Food and Drug Safety on the 11th, the approval details for Leclaza include a rarely seen statement: "The companion diagnostic medical device approved for the first-line treatment use of this drug is Panagene's 'Panamutyper R EGFR'." Leclaza is not used for all non-small cell lung cancer patients but only for those with EGFR exon 19 deletions or exon 21 substitutions as a first-line treatment. Since it is necessary to use a sufficiently validated and reliable testing method to verify the mutation status before treatment, the first-line treatment expansion approval was granted on the condition that this is done through the 'original CDx,' Panamutyper. Although Leclaza's first-line treatment has not yet been covered by the National Health Insurance, Yuhan Corporation announced the day before that it would operate an unlimited Expanded Access Program (EAP), so Panamutyper's sales are also expected to increase rapidly.

Companion diagnostics is a technology that analyzes a patient's genes, proteins, etc., before using a particular modality (treatment approach) to confirm whether they have specific biomarkers. Therefore, the companion diagnostics market is also analyzed to grow in tandem with the healthcare market. According to TechNavio, the global companion diagnostics market is expected to grow from $2.5642 billion (approximately 3.3412 trillion KRW) in 2019 at an average annual growth rate of 26.5%, reaching $8.341 billion (approximately 11 trillion KRW) by next year.

This growth trend is also why HLB recently moved to acquire Panagene, the developer of Panamutyper. In addition to Leclaza, Panagene has companion diagnostic products for EGFR mutations such as 'Tagrisso' and 'Taseva,' and also offers companion diagnostic products for various cancer types including KRAS mutations.

Will It Expand Beyond Cancer to Genetic Diseases and Dementia?

In Korea, besides Panagene, companies like GenCurix and Roche Diagnostics Korea have also received approval for companion diagnostic products. However, so far, approvals have been mainly for anticancer drugs, and expansion to other diseases has not yet occurred. Nevertheless, recently overseas, companion diagnostics are being approved together with gene therapies, indicating an expanding scope for companion diagnostics.

On the 29th of last month (local time), the U.S. Food and Drug Administration (FDA) approved BioMarin's hemophilia treatment 'Roctavian.' This ultra-high-priced drug, known to cost $2.9 million (approximately 380 million KRW), was approved for the treatment of severe hemophilia A patients without antibodies to adeno-associated virus 5 (AAV5). Hemophilia is a congenital disease caused by a deficiency of specific blood clotting factors. Hemophilia A involves a deficiency of factor VIII, and Roctavian delivers factor VIII using an AAV5-based vector; therefore, if antibodies against AAV5 are present, the drug's efficacy may be significantly reduced. For this reason, the presence or absence of AAV5 antibodies must be identified before treatment, and at this stage, the 'AAV5 Detect CDx' developed by ARUP Laboratories was developed as a companion diagnostic product and approved by the FDA together.

Biogen and Eisai's Alzheimer's dementia treatment 'Leqembi (generic name: lecanemab)' [Image source=AP Yonhap News]

Furthermore, on the 6th, Biogen and Eisai's Alzheimer's dementia treatment 'Leqembi' received formal FDA approval, raising expectations for companion diagnostics in the dementia field. Since dementia is often equated with Alzheimer's, about 70% of dementia patients suffer from Alzheimer's disease. However, this also means that 30% of dementia patients do not respond to Alzheimer's-targeting antibody treatments like Leqembi.

Therefore, it is necessary to first check whether amyloid beta (Aβ) protein is accumulating in the brain through positron emission tomography (PET) before prescribing. However, PET scans incur a cost burden exceeding 1 million KRW. For this reason, the development of diagnostic technologies using biomarkers measurable more affordably through magnetic resonance imaging (MRI), blood tests, etc., is also active. Seong Jun-kyung, CEO of NeuroXTI, which is developing an MRI-based companion diagnostic platform for antibody treatments, said, "From a pharmaceutical company's perspective, this can increase the likelihood of clinical success and reduce the risk of failure at market launch," adding, "We plan to establish standard guidelines accompanying drugs like those from Biogen and Eisai in the future."

This content was produced with the assistance of AI translation services.