Lecture Notes on Solo Latinum and its Phase 2 Trial Results

Introduction

• Solo latinum is a third-generation ALK Andrus 1 inhibitor.
• It's considered one of the more potent inhibitors currently in development.

Assessment and Trial Phases

• The drug has been assessed through Phase 1 and multi-armed Phase 2 trials.
• The focus today is on one arm of the Phase 2 trial, specifically for patients with ROS1 rearranged NSCLC (Non-Small Cell Lung Cancer).

Trial Results

Patient Cohort

• 47 patients were treated in this cohort.

Response Rate and Disease Progression

• Overall response rate: 36%
• Probability of being disease-free at one year: 47%
  • Indicates that nearly half of the patients were free from disease progression.

Prior Treatments

• More than 70% of the patients had received prior crizotinib.
• Chemotherapy is the only other option for these patients.

Brain Metastases (Brain Mets)

• 53% of the patients had brain metastases (Brain Mets) at baseline.
• Response rate in Brain Mets: 56%
  • This is quite high and significant.

Side Effects

• The side effects of the compound are well known and dose-dependent.
  • Common side effects:
    • Hypercholesterolemia (elevated cholesterol)
    • Hypertriglyceridemia (elevated triglycerides)
    • Edema (swelling)
    • Weight gain
    • Peripheral neuropathy (nerve damage)
  • Few adverse events led to treatment discontinuation

Conclusion

• Solo latinum shows promising results in treating patients with ROS1 rearranged NSCLC, especially those who have received prior treatments and have brain metastases.
• The side effects are manageable and mostly dose-dependent.