Yuhan Pharmaceuticals’ lung cancer drug Leclaza has demonstrated enhanced efficacy when combined with Johnson & Johnson’s (J&J) lung cancer treatment. Detailed data is set to be presented at a global conference on Oct. 23, heightening market anticipation.
According to industry sources on Oct. 4, Yuhan Pharmaceuticals and its global pharmaceutical partner, Johnson & Johnson (J&J), announced on Sept. 28 that the Phase 3 clinical trial of the Leclaza combination therapy was successful. This trial, named MARIPOSA, studied the effects of combining Yuhan Pharmaceuticals’ Leclaza with J&J’s Libtayo as an initial treatment for EGFR mutation lung cancer patients.
Specifically, 1,074 patients participated in the clinical trial. The study compared the combination therapy of Leclaza and Libtayo with Tagrisso’s monotherapy in the primary treatment of localized advanced and metastatic non-small cell lung cancer.
J&J highlighted that the combination therapy of Leclaza and Libtayo statistically and clinically significantly improved patients’ Progression-Free Survival (PFS) when compared to Tagrisso monotherapy. PFS indicates the duration during which a cancer patient survives without the disease progressing. It's a primary measure used to evaluate the efficacy of anticancer drugs.
The significance of J&J’s announcement is profound. This is because it can potentially challenge Tagrisso’s position as the global standard for first-line treatment for EGFR lung cancer patients. Upon releasing the clinical trial results, J&J stated, “The combination of the two drugs has heightened potential to become the future treatment standard for EGFR mutation lung cancer patients.”
The recent clinical trial results of the competing drug, Tagrisso, which fell short of market expectations, also tipped the scales in its favor. Last month, clinical data for the combination therapy of Tagrisso and a chemotherapeutic drug were disclosed at the World Conference on Lung Cancer (WCLC). While the therapy extended patients’ PFS by nine months, there were concerns about its safety, according to market evaluations.
Earlier, J&J had stated that the combination of Leclaza and Libtayo could achieve maximum annual sales of up to 5 billion dollars by 2025.
Detailed data from the MARIPOSA clinical trial will be presented at the European Society for Medical Oncology (ESMO) on Oct. 23. If a new drug approval is promptly applied for with the U.S. FDA following the conference presentation, the combination therapy of Leclaza and Libtayo is expected to receive marketing authorization by the third quarter of the following year.
Yuhan Pharmaceuticals is set to benefit from additional milestone payments and royalties post-market authorization. Yuhan Pharmaceuticals had previously transferred the Leclaza technology to J&J in 2018 for US$1.255 billion. So far, they’ve received an upfront payment of US$50 million and milestone payments of US$100 million. The remaining US$1.15 billion in milestones will be shared with Osco Tech, the original developer of Leclaza.
Meanwhile, Yuhan Pharmaceuticals’ stock price closed at 79,000 won, an increase of 3,200 won (4.22%) from the previous trading day. Earlier in the session, it reached a 52-week high of 88,400 won.