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OncoGenex Announces Encouraging Phase I Results for OGX-011 in NSCLC

Strategic Insights

— 2 min read

Clinical trials evaluating the systemic administration of OGX-011, an antisense drug, in combination with standard chemotherapy agents, have yielded promising results in patients with non-small cell lung cancer (NSCLC). The phase I study, conducted by OncoGenex Technologies Inc. in collaboration with Isis Pharmaceuticals Inc., demonstrated a 1-year survival rate of 67% for the 9 patients who received OGX-011 in combination with gemcitabine and cisplatin. Furthermore, all but one of the patients showed either a partial response or stable disease, with tumor reduction ranging from 10.3% to 29.7% for patients classified as stable disease.

Key Takeaways:

  • The phase I study demonstrated a 1-year survival rate of 67% for 9 patients with NSCLC who received OGX-011 in combination with gemcitabine and cisplatin.
  • All but one of the 9 patients showed either a partial response defined by a greater than or equal to 30% tumor size reduction, or stable disease defined by less than 30% tumor size reduction.
  • The median time for follow-up was 12.7 months, and the median time for survival had not yet been reached.
  • OGX-011 was well tolerated at the doses studied, with most toxicities being typical for gemcitabine and cisplatin.
  • The most common adverse events were constipation, change in taste, fatigue, and chills, with hematological toxicities and hyponatremia being the most common grade 3 or 4 events.
  • The study supported the ongoing phase II study evaluating OGX-011 in combination with gemcitabine and either cisplatin or carboplatin in a larger patient population of stage IIIB/IV NSCLC patients.
  • The partnership between OncoGenex and Isis provided a unique combination of OncoGenex's proprietary antisense position in inhibitors to the target, clusterin, with Isis' proprietary second-generation antisense chemistry called 2'-O-methoxyethyl.
  • Second-generation antisense drugs offer greater potency, enhanced tolerability, and improved dosing convenience compared to first-generation antisense drugs.
  • OncoGenex is developing next-generation cancer therapeutics for patients with drug-resistant and metastatic cancers.
  • The company is also conducting studies of OGX-011 in combination with neoadjuvant hormone therapy in prostate cancer, chemotherapy in hormone refractory prostate cancer, and chemotherapy in advanced breast cancer.

Statistics:

  • 1-year survival rate: 67% for patients with NSCLC who received OGX-011 in combination with gemcitabine and cisplatin.
  • 9 patients showed either a partial response or stable disease, with tumor reduction ranging from 10.3% to 29.7% for patients classified as stable disease.
  • Median time for follow-up: 12.7 months.
  • Median time for survival: not yet reached.
  • Most common adverse events: constipation, change in taste, fatigue, and chills.
  • Most common grade 3 or 4 events: hematological (60%) and hyponatremia (30%).

Sources:

  • OncoGenex Technologies Inc.
  • Isis Pharmaceuticals Inc.

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