Race Oncology Ltd (ASX:RAC) earlier this week announced that it has received ethics approval to begin a Phase 1 clinical trial of its lead drug, RC220, in combination with AstraZeneca’s Tagrisso for patients with EGFR mutant lung cancer.
The company said Tagrisso generates over USD 7 billion annually but typically loses effectiveness after 18 months due to cancer cell resistance. RC220 has demonstrated the ability to kill resistant cancer cells, potentially extending the treatment window for patients.
Race Oncology said the combination represents a strong opportunity for patients and commercial partners. CEO Dr. Daniel Tillett told investors that every additional month a patient remains on Tagrisso could equate to approximately USD 450 million in added revenue, citing the drug’s high revenue base and valuation multiples.
The trial will take place at Monash Health and has already received full ethics approval. Governance approval is pending, and patient recruitment is expected to begin in early Q1 2026. Tillett said Monash has a strong pipeline of patients currently using Tagrisso, enabling efficient enrollment.
The company also provided a broader update on RC220’s development. It recently announced a Phase 3 trial in acute myeloid leukaemia, to commence in 2026. Additionally, its cardiac protection program for patients with solid tumours is underway, with recruitment expanding beyond Australia into Hong Kong and South Korea.
Race Oncology highlighted recent discoveries related to the RC220 compound. The company said it identified that only one of the photoisomers in the molecule is active. This discovery opens the door to new composition-of-matter patent claims.
Further, it said research has clarified the drug’s mechanism of action. Rather than functioning as a traditional chemotherapeutic, RC220 appears to work through a novel biological pathway, supporting its use in a broader range of cancer types.
Race Oncology said these advances position RC220 as a multi-asset opportunity across several indications and geographies. It expects multiple clinical milestones in 2026.
Proactive: Welcome back to Proactive Newsroom. I'm now joined by Race Oncology CEO Dr. Daniel Tillett. Daniel, it's good to see you again. How are you?
Dr. Daniel Tillett: Excellent.
Proactive: There’s further progress with RC220. You’ve just gained ethics approval to launch a Phase 1 trial combining RC220 with Tagrisso for EGFR mutant lung cancer. Why is this important?
Dr. Daniel Tillett: It’s an amazing opportunity. Tagrisso, owned by AstraZeneca, generates over USD 7 billion annually for treating EGFR lung cancer. It works well initially, but after about 18 months, patients develop resistance and have few options left.
What we’ve found is that RC220 works effectively against the resistant cancer cells. We believe this combination could help patients stay on Tagrisso longer. That benefits patients and represents a significant commercial opportunity.
If AstraZeneca can extend patient treatment by even a month, that could mean around USD 450 million in added revenue. Multiply that by a PE ratio of 25, and you’re looking at billions in potential value. It’s good for patients, our shareholders, and any future partners.
Proactive: Patient enrollment at Monash Health is expected as early as next month?
Dr. Daniel Tillett: Yes, the trial has full ethics approval. We’re just waiting on governance approval at Monash — essentially a signature. My expectation is that we’ll enroll the first patient in early Q1, possibly late January or early February. Monash has a good pool of patients currently on Tagrisso, so recruitment should go smoothly.
Proactive: Can you give a quick rundown of where RC220 is heading as we close out the year?
Dr. Daniel Tillett: Recently, we announced two new trials — a Phase 3 trial in acute myeloid leukaemia, starting next year, and this EGFR lung cancer trial. We’re also progressing our cardiac protection program for solid tumours, which is already recruiting and expanding into Hong Kong and South Korea.
Additionally, we’ve made key discoveries around RC220. We identified that only one photoisomer in the compound is active, which opens up composition-of-matter patent opportunities. We’ve also worked out how the drug functions. It’s not a traditional chemotherapeutic — it works through a different mechanism that could be applied to various cancer types.
Proactive: Certainly ending the year on a high note. We look forward to more updates as Q1 2026 begins. Thanks, Daniel.
Dr. Daniel Tillett: Thank you very much.