New Combination Therapy for Advanced Small Cell, Lung Cancer Approved in Australia and Singapore

• ZEPZELCA^® (lurbinectedin), in combination with atezolizumab (Tecentriq^®), is approved for use in Australia and Singapore as a first-line maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) ^[1],[2]
• SCLC is an aggressive form of lung cancer, accounting for 10-15% of all lung cancer diagnoses ^[3]-[6]
• Lung cancer is the leading cause of cancer death in Australia and among men in Singapore, and the second highest among Singaporean women ^[7]-[9]

SINGAPORE, April 20, 2026 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) welcomes the approval of ZEPZELCA^® (lurbinectedin), in combination with atezolizumab (Tecentriq^®), as a new first-line maintenance treatment option for adult patients in Australia and Singapore, who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer.^[1],[2] This follows the recent decision by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to issue a positive opinion recommending the approval of ZEPZELCA in Europe.^[10]

In combination with atezolizumab, ZEPZELCA has been approved for use in Australia and Singapore as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.^[1],[2]

Both approvals for ZEPZELCA in ES-SCLC were obtained under Project Orbis — an initiative of the United States Food and Drug Administration's (US FDA's) Oncology Center of Excellence. These ZEPZELCA approvals represent the eighth time ST has successfully navigated the Project Orbis process since 2021.

Lung cancer remains a significant health challenge in the region, with an estimated 15,000 diagnoses and 9,000 deaths from the disease each year in Australia.^[7],[8] In Singapore, lung cancer is the third most common cancer, with 9,732 new cases diagnosed between 2019-2023.^[11] Small cell lung cancer (SCLC) is a highly aggressive cancer that has often already spread to other organs when first diagnosed.^[6] It accounts for approximately 10-15% of all lung cancer cases and has a low 5-year survival rate of under 7%.^[6]

Professor Nick Pavlakis, Medical Oncologist from Royal North Shore Hospital in Sydney, acknowledged the approval of the new combination therapy as an important step in helping to improve outcomes for patients with ES-SCLC.

"Most patients with small cell lung cancer typically present with extensive-stage disease at diagnosis, meaning they are often faced with experiencing high rates of relapse or recurrence, limited treatment options and a poor prognosis," said Professor Pavlakis.

"While outcomes for patients have improved over the past five years with the addition of immunotherapy to chemotherapy, there continues to be a significant clinical need to improve on first-line therapies used to treat extensive-stage small cell lung cancer to prolong disease control and enhance survival. Today's announcement is welcome news for the medical and patient community."

ZEPZELCA  is being made available in Australia, New Zealand, Singapore, Malaysia, Thailand and Vietnam by Specialised Therapeutics (ST), under exclusive license from European biopharmaceutical company PharmaMar, which has pioneered the development of marine-based oncology medicines.

ST Chief Executive Officer, Mr Carlo Montagner, said the approval of ZEPZELCA for ES-SCLC in the first-line setting would provide clinicians and patients with an important new therapeutic option for this difficult to treat cancer.

"We are delighted to have secured regulatory approvals for ZEPZELCA in combination with atezolizumab as a first-line maintenance therapy for adults diagnosed with ES-SCLC in Australia and Singapore," said Mr Montagner.

"Despite the improved efficacy of first-line therapies for ES-SCLC that have been available since 2019, survival outcomes remain suboptimal, with an estimated 40% of patients experiencing a relapse and requiring second-line treatment. The availability of additional first-line treatment options will enable eligible patients and their clinicians to find the therapy that is right for them, can help to improve their quality of life and importantly, give them more time to spend with their families and loved ones."

Chief Medical Officer for PharmaMar, Javier Jimenez, welcomed the regulatory approval for ZEPZELCA, saying: "We are very pleased that patients in Australia and Singapore can have access to this new therapy, as it marks an important milestone in the management of this disease, where a significant unmet medical need persists. Building on more than 40 years of commitment to research in diseases with limited treatment options, we will continue to collaborate with our partner in Australia to enable timely and equitable access to this new treatment."

ZEPZELCA belongs to a class of medicines known as alkylating agents, which work by damaging the DNA of cancer cells, helping to slow or stop their growth.^[12] The regulatory approvals for ES-SCLC in Australia and Singapore were based on results from the Phase 3 IMforte clinical trial. The study enrolled 660 treatment-naïve patients with ES-SCLC across 13 countries in the induction phase. Following this, 483 patients who responded to induction treatment were randomised to receive either ZEPZELCA with atezolizumab (LU-AT) or atezolizumab monotherapy (AT) as first-line maintenance therapy.^[13] The trial results supported the use of LU-AT as a new first-line maintenance treatment option over AT alone in patients with this aggressive cancer, with improvements recorded in both median progression free survival (PFS; 5.4 months vs. 2.1 months) and median overall survival (OS; 13.2 months vs.10.6 months).^[13]

Significant variations in treatment-related adverse events (AEs) were noted in the two trial groups (83.5% in patients receiving LU-AT vs. 40% among patients receiving AT monotherapy).^[13] Treatment with LU-AT was considered to be generally well tolerated, with no new or unexpected safety signals.^[13] The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes, decreased platelets, decreased haemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.

For further details on ZEPZELCA, contact your healthcare professional and refer to the approved Australian Consumer Medicine Information, available from the TGA's website.*

PBS Information: ZEPZELCA is not listed on the Pharmaceutical Benefits Scheme (PBS).

Ends.

*Administrative processing times vary and may impact availability of the revised CMI.

About ZEPZELCA

ZEPZELCA® (lurbinectedin), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumours are particularly dependent. Together with its effect on cancer cells, ZEPZELCA inhibits oncogenic transcription in tumour-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumour. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.

In Australia and Singapore, ZEPZELCA  is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy.^[1],[2]

ZEPZELCA® is a registered trademark of PharmaMar SA.

ZEPZELCA® is under license from PharmaMar SA.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About the IMForte Study^[6],[13]

The IMforte clinical trial was a randomised, multicentre, open-label, Phase 3 trial of 660 treatment-naive patients with ES-SCLC conducted across 96 hospitals and medical centres in 13 countries, including Belgium, Germany, Greece, Hungary, Italy, Mexico, Poland, South Korea, Spain, Taiwan, Türkiye, the UK and the US. The trial evaluated the efficacy and safety of lurbinectedin (ZEPZELCA®) combined with atezolizumab (Tecentriq®) as first-line maintenance therapy (LU-AT), compared to treatment with atezolizumab alone (AT) for patients with ES-SCLC, following first-line induction therapy with atezolizumab, carboplatin and etoposide. Of the 660 enrolled patients, 483 were randomised to receive treatment with LU-AT (n=242) or AT monotherapy (n=241).

The IMforte trial demonstrated that treatment with LU-AT as a first line regimen offers clinical advantages over AT alone in patients with ES-SCLC, with significant improvements to median progression-free survival (PFS; 5.4 months vs. 2.1 months) and median overall survival (13.2 months vs.10.6 months) observed. Treatment-related adverse events (AEs) occurred in 83.5% of patients who received LU-AT, compared with 40% in the AT arm. This variation was observed in patients who experienced a grade 3/4 AE (25.6% vs. 5.8%), a grade 5 AE (0.8% vs. 0.4%) and AEs that led to treatment discontinuation (6.2% vs. 3.3%). However, treatment with LU-AT was considered to be generally well tolerated, with no new or unexpected safety signals. The trial results suggest that LU-AT may serve as a novel first-line maintenance treatment option for patients with ES-SCLC.

About Specialised Therapeutics

Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas.     

Additional information can be found at www.stbiopharma.com.

About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercialises Yondelis® in Europe by itself, as well as ZEPZELCA® (lurbinectedin), in the US; and Aplidin® (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and The United States. PharmaMar also wholly owns Sylentis, a company dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com

SOURCE Specialised Therapeutics