Immuno-oncology, which harnesses the patient’s immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD modeling and simulation (M&S) has played a growing role in oncology drug development. M&S (also known as biosimulation) can help support some of the unique challenges that immuno-oncology programs face.
When it comes to immuno-oncology treatments, everything old is new again. In the late 19th century, an intrepid physician named William Coley was struck by the case of a deathly ill cancer patient who made a seemingly miraculous recovery after contracting a serious bacterial infection. This strange case inspired him to deliberately infect another cancer patient with bacteria. Again, the patient who was suffering from an advanced-stage sarcoma, recovered. Dr. Coley kept refining his treatment, known as Coley’s toxins. A lack of understanding of the immune system meant that no one knew exactly how this treatment worked. Eventually, Coley’s toxins fell into disuse with the emergence of radiation therapy in the early 20th century.