Chasing rivals, Nuvalent to seek approval of targeted lung cancer drug – BioPharma Dive

Report on Nuvalent’s Targeted Lung Cancer Drug and Its Implications for Sustainable Development Goals (SDGs)

Overview of Clinical Trial Results

1. Nuvalent announced positive pivotal data from the ARROS-1 clinical trial involving its targeted lung cancer drug, zidesamtinib.
2. The drug demonstrated tumor responses in approximately 50% of patients who had previously undergone at least one similar therapy, and 44% response in those treated with two or more similar medicines.
3. The trial focused on patients with metastatic non-small cell lung cancer (NSCLC) exhibiting ROS1 gene alterations, many of whom had prior treatment with tyrosine kinase inhibitors (TKIs) and chemotherapy.
4. Nuvalent plans to use these data to support a U.S. approval application for pre-treated patients, expected to be completed in Q3 2025.
5. The company is also investigating zidesamtinib in treatment-naïve ROS1-positive lung cancer patients and is in discussions with the FDA regarding a potential line-agnostic expansion of the drug’s indication.

Context within the Lung Cancer Treatment Landscape

• Approximately 2% of NSCLC patients have ROS1-positive mutations, a subgroup targeted by zidesamtinib.
• Existing treatments include Pfizer’s Xalkori, Roche’s Rozlytrek, and Bristol Myers Squibb’s Augtyro; however, these drugs have experienced limited commercial success.
• Challenges with current therapies include neurological side effects, resistance mutations, and brain metastases, contributing to slow uptake.
• Nuvalent’s drug aims to address these issues through increased selectivity for ROS1-positive NSCLC, potentially offering longer-lasting therapeutic effects.
• Despite a later market entry compared to competitors like Nuvation Bio’s Ibtrozi, zidesamtinib’s durability of response may provide a competitive advantage.

Durability and Tolerability of Zidesamtinib

1. Median follow-up of 11 months showed that 78% of responses lasted at least one year, and 62% persisted for 18 months.
2. Among patients with prior exposure to one TKI, 93% of responses were maintained at 12 and 18 months.
3. Comparative analysis suggests zidesamtinib may have superior duration of response relative to Ibtrozi, with similar tolerability profiles.
4. These factors support a potentially greater commercial opportunity due to extended treatment duration.

Emphasis on Sustainable Development Goals (SDGs)

SDG 3: Good Health and Well-being

• Nuvalent’s development of zidesamtinib directly contributes to SDG 3 by advancing treatments for lung cancer, a leading cause of mortality worldwide.
• Improved therapeutic options for ROS1-positive NSCLC patients enhance survival rates and quality of life.
• The focus on reducing side effects and overcoming resistance aligns with the goal of ensuring healthy lives and promoting well-being for all ages.

SDG 9: Industry, Innovation, and Infrastructure

• The clinical trial and drug development process exemplify innovation in the pharmaceutical industry, fostering scientific research and technological progress.
• Nuvalent’s targeted therapy approach highlights advancements in precision medicine, contributing to resilient infrastructure and sustainable industrialization.

SDG 17: Partnerships for the Goals

• Collaboration with regulatory bodies such as the FDA demonstrates effective partnerships essential for achieving health-related SDGs.
• Engagement with the broader scientific and medical community supports knowledge sharing and resource mobilization.

Conclusion

Nuvalent’s zidesamtinib shows promising efficacy and durability in treating ROS1-positive NSCLC patients, addressing significant unmet medical needs. The drug’s development and potential approval align with multiple Sustainable Development Goals, particularly those focused on health, innovation, and partnerships. Continued research and regulatory progress will be critical to maximizing its impact on patient outcomes and contributing to global health objectives.

1. Sustainable Development Goals (SDGs) Addressed or Connected to the Issues Highlighted in the Article

1. SDG 3: Good Health and Well-being
   • The article discusses advancements in lung cancer treatment, specifically targeting ROS1-positive non-small cell lung cancer (NSCLC), which directly relates to ensuring healthy lives and promoting well-being for all ages.
2. SDG 9: Industry, Innovation and Infrastructure
   • The development of targeted drugs like zidesamtinib reflects innovation in pharmaceutical research and development, contributing to building resilient infrastructure and fostering innovation.

2. Specific Targets Under Those SDGs Identified Based on the Article’s Content

1. SDG 3: Good Health and Well-being
   • Target 3.4: By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.
   • Target 3.8: Achieve universal health coverage, including access to quality essential health-care services and access to safe, effective, quality, and affordable essential medicines and vaccines for all.
2. SDG 9: Industry, Innovation and Infrastructure
   • Target 9.5: Enhance scientific research, upgrade the technological capabilities of industrial sectors, and encourage innovation.

3. Indicators Mentioned or Implied in the Article to Measure Progress Towards the Identified Targets

1. For SDG 3 Targets:
   • Indicator 3.4.1: Mortality rate attributed to cardiovascular disease, cancer, diabetes or chronic respiratory disease.
   • Indicator 3.8.1: Coverage of essential health services (defined as the average coverage of essential services based on tracer interventions, including cancer treatment).
   • The article implies measuring treatment efficacy through clinical trial outcomes such as:
     • Tumor response rates (e.g., about 50% tumor responses in pre-treated patients)
     • Duration of response (e.g., 78% of responses lasting at least a year, 62% lasting 18 months)
     • Comparative effectiveness and tolerability of drugs
2. For SDG 9 Targets:
   • Indicator 9.5.1: Research and development expenditure as a proportion of GDP.
   • Indicator 9.5.2: Number of researchers per million inhabitants.
   • The article implies innovation progress through:
     • Development and clinical trial results of new targeted therapies like zidesamtinib
     • Regulatory approval processes and market introduction of innovative drugs

4. Table of SDGs, Targets, and Indicators

Source: biopharmadive.com