- Noxopharm presented two sets of clinical data concerning the development of Veyonda® as a treatment for end-stage prostate cancer at ASCO 2020 Annual Meeting.
- Highly encouraging interim data from the Phase 1b/2a LuPIN clinical trial and data on the DARRT-1 Phase 1b clinical study were presented in detail at the event.
- Data supports Noxopharm’s confidence in the prominent position of Veyonda® against competitive therapies in end-stage prostate cancer.
- Noxopharm plans to conduct an expanded version of DARRT-1 in 2021, while continuously monitoring the fully recruited LuPIN study.
In a latest development, Noxopharm (ASX: NOX) notified that two sets of clinical data concerning the development of Veyonda® (NOX66) as a treatment of end-stage prostate cancer were presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting.
The premier annual scientific event in the oncology field, ASCO Annual Meeting, offered an opportunity to the pharmaceutical industry, the investment market and Noxopharm to yardstick Veyonda® against competitive therapies in end-stage prostate cancer.
The data presented by Noxopharm at ASCO conferred strong validation of the Company’s work in prostate cancer. Two sets of data presented at the global oncology conference include:
- Details of the DARRT-1 Phase 1b clinical study
- Interim data from the Phase 1b/2a LuPIN clinical trial
Noxopharm is expected to make available a webcast recording of the 2020 ASCO poster presentations later this week, discussed by CEO and Executive Chairman, Dr Graham Kelly and Chief Medical Officer, Dr Gisela Mautner.
Abscopal Responses Attained in DARRT-1 Study
Noxopharm presented results of its DARRT-1 study at ASCO, discussing the remarkable achievement of attaining exceptionally rare abscopal responses in four patients following DARRT combination therapy. These patients were given a combination therapy of NOX66 and low-dose radiation, which shrunk irradiated lesions, along with lesions outside the radiation field.
Below are the key outcomes from the DARRT-1 Study:
- 10 out of 15 patients (67 per cent) scanned at 6 months after start of study had responded to treatment with stable disease or better.
- 4 out of 15 patients (27 per cent) reported an abscopal response (in non-irradiated lesions, abscopal responses varied from about 50 per cent shrinkage of the abscopal lesion to nearly complete resolution).
- 10 out of 16 patients (63 per cent) reported a significant reduction in pain levels, including 4 patients attaining a pain-free state.
- 5 out of 16 patients (31 per cent) had a clinically significant PSA response.
In addition, DARRT combination therapy (Veyonda® + external beam radiotherapy) was well tolerated and had a favourable safety profile with no new adverse safety signals.
Pronounced Survival Benefit Demonstrated in LuPIN Study
Noxopharm also presented highly encouraging results from its LuPIN trial (Veyonda® in combination with 177Lu-PSMA-617), that demonstrated a pronounced survival benefit in patients with end-stage prostate cancer, who often have a poor quality of life and limited survival expectancy.
Below are the key outcomes from the LuPIN trial:
- Median Overall Survival was 17.1 months in 32 men, a great clinical achievement for end-stage prostate cancer patients.
- 20 out of 32 patients (62.5 per cent) had an anti-cancer effect, as shown by a reduction in PSA response of over 50 per cent.
- 12 out of 24 patients (50 per cent) who had severe pain at the beginning of the study witnessed a considerable pain reduction.
- 15 out of 32 patients (47 per cent) were able to finish the full six courses of treatment.
In addition, the combination treatment in the LuPIN trial was safe and well tolerated in end-stage prostate cancer patients.
Noxopharm has planned to undertake an expanded version of DARRT-1 in 2021, with the DARRT program being its primary focus at present. The DARRT-2 trial will be a multi-national Phase 2 study in patients with metastatic castrate-resistant prostate cancer after 2 rounds of taxane therapy and novel anti-androgen therapies.
In contrast to the DARRT-1 trial, repeated cycles of Veyonda® will be used in the DARRT-2 trial to maximise its monotherapy anti-cancer effect. DARRT-2 trial’s planning is currently in progress, including an approaching lodgement of an IND with the U.S. FDA.
Moreover, Noxopharm will continue to monitor the fully recruited LuPIN study in order to use Veyonda® to improve the efficacy of the experimental radiopharmaceutical, 177Lutetium-PSMA-617.
NOX traded at $0.195 on 3 June 2020 (11:19 AM AEST).