CLINICAL TRIALS PROFILE FOR LURBINECTEDIN

All Clinical Trials for lurbinectedin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02421588 ↗	Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients	Completed	PharmaMar	Phase 3	2015-05-01	Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
NCT01980667 ↗	Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors	Completed	PharmaMar	Phase 1	2014-07-30	Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.
NCT01951157 ↗	A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients	Completed	PharmaMar	Phase 2	2013-09-11	A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients
NCT01831089 ↗	Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors	Completed	PharmaMar	Phase 1	2013-09-01	Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors
NCT02210364 ↗	Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).	Completed	PharmaMar	Phase 1	2013-04-01	Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.
NCT01314599 ↗	Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome	Completed	PharmaMar	Phase 1	2011-05-01	Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183.

Clinical Trial Conditions for lurbinectedin

Condition Name

Condition Name for lurbinectedin
Intervention	Trials
Advanced Solid Tumor	5
Small-cell Lung Cancer	5
Ovarian Cancer	4
Advanced Solid Tumors	3

Condition MeSH

Condition MeSH for lurbinectedin
Intervention	Trials
Lung Neoplasms	12
Small Cell Lung Carcinoma	11
Neoplasms	7
Sarcoma	6

Clinical Trial Locations for lurbinectedin

Trials by Country

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Trials by Country for lurbinectedin
Location	Trials
United States	90
Spain	24
Italy	12
United Kingdom	7
France	7

Trials by US State

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−

Trials by US State for lurbinectedin
Location	Trials
Massachusetts	9
Texas	8
California	7
Pennsylvania	6
New York	5

Clinical Trial Progress for lurbinectedin

Clinical Trial Phase

Clinical Trial Phase for lurbinectedin
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	11

Clinical Trial Status

Clinical Trial Status for lurbinectedin
Clinical Trial Phase	Trials
Not yet recruiting	15
Completed	10
Recruiting	9

Clinical Trial Sponsors for lurbinectedin

Sponsor Name

Sponsor Name for lurbinectedin
Sponsor	Trials
PharmaMar	19
Jazz Pharmaceuticals	9
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for lurbinectedin
Sponsor	Trials
Industry	36
Other	19
NIH	3

Lurbinectedin: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Lurbinectedin

Lurbinectedin, also known as Zepzelca or PM1183, is a novel synthetic chemical entity derived from the marine compound ET-736, isolated from the sea squirt Ecteinacidia turbinate. It acts as an inhibitor of oncogenic transcription, making it particularly effective in tumors dependent on transcriptional programs[3].

Clinical Trials and Efficacy

Phase II Basket Trial

In a phase II basket trial (NCT02454972), lurbinectedin demonstrated significant efficacy in patients with small cell lung cancer (SCLC). The trial showed an overall response rate (ORR) of 35.2% and a median duration of response (DoR) of 5.3 months, with 43.0% of responses lasting six months or more. These results led to the accelerated approval of lurbinectedin by the US FDA for the treatment of adult patients with metastatic SCLC who have experienced disease progression on or after platinum-based chemotherapy[1][2].

Phase III Trials

The LAGOON trial (NCT05153239) is an ongoing phase III clinical trial evaluating lurbinectedin alone or in combination with irinotecan versus topotecan or irinotecan in patients with SCLC who have failed one prior platinum-containing line. Preliminary results from a phase I/II trial (NCT02611024) showed an ORR of 62% and a median DoR of 5.7 months, supporting the expansion to a phase III trial[1][2].

IMforte Trial

The phase 3 IMforte trial (NCT05091567) has shown promising results for the combination of lurbinectedin and atezolizumab as frontline maintenance therapy for extensive-stage SCLC. The trial demonstrated statistically significant overall survival (OS) and progression-free survival (PFS) benefits compared to atezolizumab monotherapy. This combination is generally well-tolerated, with no new safety signals reported[4][5].

Comparative Efficacy and Safety

Lurbinectedin vs Topotecan

A post hoc analysis of the phase II basket trial and the phase 3 ATLANTIS trial revealed that lurbinectedin has a superior risk/benefit ratio compared to topotecan in patients with SCLC. Lurbinectedin showed a higher ORR (41% vs 25.5%) and was less toxic and better tolerated than topotecan[2].

Market Analysis and Projections

Market Growth

The global lurbinectedin market is expected to grow at a rate of 45.30% from 2022 to 2029. This growth is driven by the increasing prevalence of cancer, advancements in tumor treatment technologies, and the surge in approvals and uptake of premium-priced targeted therapies[3].

Market Segmentation

The lurbinectedin market is segmented by drug classification, end-users, and distribution channels. Key end-users include hospitals, specialty clinics, and ambulatory surgical centers. Distribution channels primarily involve hospital pharmacies, retail pharmacies, and online pharmacies[3].

Key Players

Major players in the lurbinectedin market include F. Hoffmann La Roche Ltd, Novartis AG, Bayer AG, GlaxoSmithKline plc, Sanofi, and others. These companies are investing heavily in research and development, new market initiatives, and global expansions to capitalize on the growing demand for lurbinectedin[3].

Global Availability and Regulatory Approvals

Current Availability

Lurbinectedin is currently available in 16 regions globally, including Taiwan, where it was granted accelerated approval by the Taiwan Food and Drug Administration (TFDA) in 2023 for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after platinum-based chemotherapy[5].

Challenges and Opportunities

Market Challenges

Despite the promising growth, the lurbinectedin market faces challenges such as the availability of various classes of drugs and low awareness among patients. These factors are expected to obstruct market growth to some extent[3].

Market Opportunities

The rise in healthcare expenditure, changes in lifestyle, an increase in the geriatric population, and developments in the biotechnology sector present profitable opportunities for market players. The ongoing clinical trials and potential approvals for new indications are expected to further boost the market[3].

Conclusion

Lurbinectedin has emerged as a significant player in the treatment of small cell lung cancer, particularly in the second-line setting. Its superior efficacy and safety profile compared to other treatments, such as topotecan, and its potential in combination therapies with atezolizumab, highlight its clinical value.

Key Takeaways

• Clinical Efficacy: Lurbinectedin has shown high ORR and durable responses in SCLC patients, leading to accelerated FDA approval.
• Market Growth: The global lurbinectedin market is projected to grow at a rate of 45.30% from 2022 to 2029.
• Comparative Safety: Lurbinectedin is less toxic and better tolerated than topotecan.
• Global Availability: Currently available in 16 regions, with ongoing efforts to expand accessibility.
• Future Prospects: Combination therapies, such as with atezolizumab, show promising results and potential for further approvals.

FAQs

Q: What is lurbinectedin and how does it work?

A: Lurbinectedin is a synthetic chemical entity that inhibits oncogenic transcription, particularly effective in tumors dependent on transcriptional programs.

Q: What are the key clinical trials for lurbinectedin?

A: The LAGOON trial and the IMforte trial are significant ongoing phase III trials evaluating lurbinectedin alone or in combination with other agents for SCLC.

Q: How does lurbinectedin compare to topotecan in treating SCLC?

A: Lurbinectedin has shown a superior risk/benefit ratio compared to topotecan, with higher ORR and better tolerability.

Q: What is the current market growth projection for lurbinectedin?

A: The global lurbinectedin market is expected to grow at a rate of 45.30% from 2022 to 2029.

Q: Where is lurbinectedin currently available?

A: Lurbinectedin is currently available in 16 regions globally, including Taiwan, where it was granted accelerated approval in 2023.

References

1. ASCO Publications: A phase III study of lurbinectedin alone or in combination with irinotecan...
2. Onclive: Lurbinectedin Displays Superior Risk/Benefit Ratio Over Topotecan...
3. Data Bridge Market Research: Global Lurbinectedin Market - Industry Trends and Forecast to 2029
4. Onclive: Lurbinectedin/Atezolizumab Combination Improves Survival in ES-SCLC
5. Lotus Pharmaceutical: Zepzelca® (lurbinectedin) Combo Trial Enrollment Update