At ASCO- GU there was an interim data release from the LuPIN phase I/II clinical trial that holds great promise for men who have end-stage prostate cancer. The data analyzed the survival benefit of 32 men with end stage prostate cancer who were treated with the combination of Veyonda® and 177Lu-PSMA-617.
The data release showed:
• Median Overall Survival was very long (17.1 months), a remarkable outcome for end-stage prostate cancer
• 62.5% of the men had an anti-cancer effect as evidenced by a PSA response and half of the men who were experiencing severe pain reported a significant reduction in their pain
• 47% of the men were able to complete the full 6 courses of treatment
• Combination of these treatments was safe and well tolerated
• The final 24 men will now receive combinations with higher Veyonda® dose (1200 mg)
This trial is being conducted by St Vincent’s Hospital Sydney, Australia
Dr Gisela Mautner, Noxopharm Chief Medical Officer, said:
“Today’s results are highly encouraging for patients, for Noxopharm and for the St Vincent’s Hospital Sydney team. The study reported an unprecedented median Overall Survival of 17.1 months in a patient group that normally would have a much shorter survival expectation. The combination treatment of Veyonda® and 177 a radiopharmaceutical therapy, in 56 patients with metastatic castration-resistant prostate cancer (mCRPC)
These interim results are highly relevant for a patient group that is at the very end of their treatment journey with very limited life expectancy. The data boosts our confidence that will prove to be of major benefit for a high proportion of patients with late-stage prostate cancer. “
A subject profile showed how advanced the men were. All the men had received and failed two prior lines of therapy (chemotherapy and androgen- signaling inhibitors) and most men (29/32) had failed a third line of therapy (another chemotherapy) prior to entering the trial.
The advanced nature of the disease in the LuPIN men is highlighted by the following:
• The extensive treatment history of most LuPIN subjects means that their disease is more advanced and more resistant to therapy than in other studies where subjects have had fewer lines of drug therapy
• The majority of the subject men (65%) had a significant tumor burden with over 20 secondary tumors mainly in the bones and lymph nodes
• All men had progressive end-stage prostate cancer.
Phase I/II trials usually are not designed to show efficacy yet there were a number of encouraging efficacy findings including:
• Median Overall Survival was 17.1 months, indicating a significantly longer survival duration than clinically expected (there was not any matched control group because of the design of phase I/II trials)
• 47% of the subject men (15/32) were well enough to receive all 6 cycles of therapy, indicating a durable response, enabling them to continue to receive treatment until the end of the study
• 87% of the men (28/32) had a fall in PSA (an important marker for anti-cancer activity) and 62.5% (20/32) had a strong PSA response of over 50%
• Half of the subject men with severe pain at study start (12/24) had a significant reduction of their pain due to the secondary tumors, supporting the above efficacy results.
Efficacy summary: The combination treatment had a beneficial impact in more than half of the subject men.
The trial also demonstrated a number of key safety findings:
Veyonda® combined with 177Lu-PSMA-617 continues to have a good safety profile, with approximately half the subject men experiencing only mild adverse events, such as dry mouth (17/32), fatigue (15/32) and anemia (14/32). Minimal higher-grade side effects were reported and all were manageable.
What is Veyonda®
Veyonda® is a suppository dosage form of idronoxil, a first-in-class inhibitor of sphingosine-1-phosphate (S1P). S1P is a key secondary messenger in cells, with dual roles of activating major pro-survival signaling pathways and regulating immune cell trafficing in tissues. Many solid cancers over-express S1P, supporting unregulated tumor growth and suppressing immune cell populations and activities in tumors. By inhibiting this over- expression, idronoxil acts as both a radio-sensitizer and chemo-sensitizer, and as an immunotherapy,
