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Lotus Pharmaceutical's novel drug Zepzelca® (lurbinectedin) has demonstrated significantly superior efficacy in First-line maintenance therapy for Small Cell Lung Cancer (ES-SCLC) when combined with Atezolizumab

Business
30 October 2024

Taipei, Taiwan, October 30, 2024 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a global pharmaceutical leader headquartered in Taiwan, would like to share that, its licensed product, a novel small-cell lung cancer (SCLC) drug Zepzelca® (lurbinectedin) when combined with atezolizumab, has shown statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared to treatment with atezolizumab alone. This result was observed in the Phase III IMforte clinical trial (NCT05091567), led by Spain-based PharmaMar S.A. and U.S.-based Jazz Pharmaceuticals where the combination was administered as a maintenance therapy for adult patients with extensive-stage small-cell lung cancer (ES-SCLC), who had previously received platinum-based chemotherapy and atezolizumab as induction therapy. Both PharmaMar and Jazz Pharmaceuticals plan to submit regulatory filings to the European Medicines Agency (EMA) and the U.S. FDA in the first half of 2025(1).

Small-cell lung cancer (SCLC) accounts for approximately 10-15% of all lung cancer cases, with around 1,000 new cases diagnosed annually in Taiwan, most of which are in the extensive stage(2). SCLC is known for its aggressiveness, treatment challenges, and poor prognosis. First-line induction treatment typically involves a combination of atezolizumab immunotherapy with platinum-based chemotherapy, followed by atezolizumab maintenance therapy. For patients who continue to progress, lurbinectedin is available as a second-line treatment and is recommended in NCCN guideline. Depending on the dosage, the cost per treatment cycle ranges from NT$80,000 to NT$160,000(3). To date, approximately 220 SCLC patients in Taiwan have received lurbinectedin treatment(4).

The results of the IMforte trial are highly encouraging, showing that the addition of lurbinectedin to atezolizumab maintenance therapy can significantly delay disease progression and extend SCLC patient survival. With an estimated one-year survival rate of 51.9%(5), it is projected that around 500-600 patients in Taiwan could benefit from the combination of lurbinectedin and atezolizumab annually.

Lurbinectedin is currently available in 16 regions globally, and in Taiwan, it is approved for "the treatment of adult patients with metastatic SCLC whose disease has progressed during or after platinum-based chemotherapy." In late 2021, Lotus signed an exclusive agreement with PharmaMar S.A., securing the exclusive distribution rights for the Taiwan market. In 2023, the Taiwan Food and Drug Administration (TFDA) granted accelerated approval for the drug. Lotus is also actively seeking reimbursement approval from Taiwan’s National Health Insurance Administration, hoping to make this treatment accessible to more SCLC patients in the future.

 

References:

(1)   PharmaMar Announces Positive and Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination in First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

https://pharmamar.com/en/pharmamar-announces-positive-and-statistically-significant-overall-survival-and-progression-free-survival-results-for-zepzelca-lurbinectedin-and-atezolizumab-combination-in-first-line-maintena/

(2)   Taiwan Cancer Registry Report p. 594

(3)   Lotus Taiwan

(4)   Lotus Taiwan

(5)   NCCN guideline for SCLC

 

About Lotus

Founded in 1966, Lotus (1795: TT) is a global pharmaceutical company focused on delivering novel and generic medicines that are safer, better, and more accessible. With a best-in-class R&D and manufacturing platform in Asia, Lotus has partnerships in key markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in development and registration across Asia and the U.S., with a portfolio of more than 250 commercial products. Lotus invests in a diversified pipeline of high-barrier oncology treatments, complex generics, 505(b)2 products, and new chemical entities (NCEs), through internal R&D and licensing partnerships. Additionally, it bolsters its portfolio with biosimilars, supported by strategic alliances. Lotus's facilities are certified by top regulatory bodies, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.

Media Inquiries:

Yu-ying Yang, Associate Director, Corporate communication.

+886 2 2700 5908

investor@lotuspharm.com