ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress
ESSA Pharma presented updated Phase 1/2 clinical data for masofaniten (EPI-7386) in combination with enzalutamide at the 2024 ESMO Congress. The study focused on patients with metastatic castration-resistant prostate cancer (mCRPC). Key findings include:
- 88% of patients achieved PSA90
- 69% achieved PSA90 in less than 90 days
- 63% achieved PSA <0.2ng/mL
- After 15.2 months, median time to PSA progression and radiographic progression-free survival not yet reached
- Combination well-tolerated with durable PSA reductions
- Phase 2 dose expansion ongoing at RP2CDs of masofaniten 600 mg BID with enzalutamide 160 mg QD
The data suggests favorable outcomes compared to historical single-agent enzalutamide treatment in mCRPC patients.
ESSA Pharma ha presentato dati clinici aggiornati della Fase 1/2 per masofaniten (EPI-7386) in combinazione con enzalutamide al Congresso ESMO 2024. Lo studio si è concentrato su pazienti con carcinoma prostatico metastatico resistente alla castrazione (mCRPC). I principali risultati includono:
- L'88% dei pazienti ha raggiunto PSA90
- Il 69% ha raggiunto PSA90 in meno di 90 giorni
- Il 63% ha ottenuto PSA <0.2ng/mL
- Dopo 15,2 mesi, il tempo mediano fino alla progressione del PSA e la sopravvivenza libera da progressione radiografica non sono stati ancora raggiunti
- La combinazione è ben tollerata con riduzioni durature del PSA
- Espansione della dose della Fase 2 in corso a RP2CDs di masofaniten 600 mg BID con enzalutamide 160 mg QD
I dati suggeriscono risultati favorevoli rispetto al trattamento con enzalutamide in monoterapia in pazienti con mCRPC.
ESSA Pharma presentó datos clínicos actualizados de la Fase 1/2 para masofaniten (EPI-7386) en combinación con enzalutamida en el Congreso ESMO 2024. El estudio se centró en pacientes con cáncer de próstata metastásico resistente a la castración (mCRPC). Los hallazgos clave incluyen:
- El 88% de los pacientes logró PSA90
- El 69% alcanzó PSA90 en menos de 90 días
- El 63% logró PSA <0.2ng/mL
- Después de 15.2 meses, el tiempo medio hasta la progresión del PSA y la supervivencia libre de progresión radiográfica no se han alcanzado aún
- La combinación fue bien tolerada con reducciones duraderas de PSA
- La expansión de la dosis de la Fase 2 está en curso con RP2CDs de masofaniten 600 mg BID y enzalutamida 160 mg QD
Los datos sugieren resultados favorables en comparación con el tratamiento con enzalutamida como monoterapia en pacientes con mCRPC.
ESSA Pharma는 2024 ESMO Congress에서 enzalutamide와 함께 masofaniten (EPI-7386)의 1/2상 임상 데이터 업데이트를 발표했습니다. 이 연구는 전이성 거세 저항성 전립선암 (mCRPC) 환자에 초점을 맞췄습니다. 주요 결과는 다음과 같습니다:
- 환자의 88%가 PSA90을 달성함
- 69%가 90일 이내에 PSA90을 달성함
- 63%가 PSA <0.2ng/mL을 달성함
- 15.2개월 후, PSA 진행 및 방사선 진행 없는 생존의 중앙 시간은 아직 도달하지 못함
- 조합이 잘 견뎌졌으며 지속적인 PSA 감소를 보임
- masofaniten 600 mg BID와 enzalutamide 160 mg QD의 RP2CDs에서 2상 용량 확장이 진행 중임
데이터는 mCRPC 환자에서 역사적인 단일 약제 enzalutamide 치료와 비교하여 유리한 결과를 제시합니다.
ESSA Pharma a présenté des données cliniques mises à jour de la phase 1/2 pour masofaniten (EPI-7386) en combinaison avec l'enzalutamide lors du Congrès ESMO 2024. L'étude s'est concentrée sur des patients atteints de cancer de la prostate métastatique résistant à la castration (mCRPC). Les résultats clés incluent :
- 88 % des patients ont atteint PSA90
- 69 % ont atteint PSA90 en moins de 90 jours
- 63 % ont obtenu un PSA <0,2ng/mL
- Après 15,2 mois, le temps médian jusqu'à la progression du PSA et la survie sans progression radiographique n'ont pas encore été atteints
- La combinaison est bien tolérée avec des réductions durables du PSA
- L'expansion de la dose de la phase 2 est en cours avec des RP2CDs de masofaniten 600 mg BID et enzalutamide 160 mg QD
Les données suggèrent des résultats favorables par rapport au traitement historique par enzalutamide en monothérapie chez les patients atteints de mCRPC.
ESSA Pharma präsentierte aktualisierte klinische Daten der Phase 1/2 für masofaniten (EPI-7386) in Kombination mit Enzalutamid auf dem ESMO-Kongress 2024. Die Studie konzentrierte sich auf Patienten mit metastasiertem kastrationsresistentem Prostatakrebs (mCRPC). Zu den wichtigen Ergebnissen gehören:
- 88% der Patienten erreichten PSA90
- 69% erreichten PSA90 in weniger als 90 Tagen
- 63% erreichten PSA <0,2ng/mL
- Nach 15,2 Monaten wurde der mediane Zeitraum bis zur PSA-Progression und das radiographiefreie Überleben noch nicht erreicht
- Kombination gut verträglich mit nachhaltigen PSA-Reduktionen
- Die Erweiterung der Dosis in Phase 2 läuft mit RP2CDs von masofaniten 600 mg BID und Enzalutamid 160 mg QD
Die Daten deuten auf günstige Ergebnisse im Vergleich zur historischen Behandlung mit Einzelwirkstoffen wie Enzalutamid bei mCRPC-Patienten hin.
- 88% of patients achieved PSA90, indicating strong efficacy
- Median time to PSA progression and radiographic progression-free survival not reached after 15.2 months
- Combination of masofaniten and enzalutamide well-tolerated
- Phase 2 dose expansion study underway with 33 sites activated
- Data compares favorably to historical single-agent enzalutamide treatment
- One patient experienced a Grade 3 rash, possibly related to treatment
Insights
The updated Phase 1/2 data for masofaniten (EPI-7386) in combination with enzalutamide shows promising results for mCRPC treatment. Key findings include:
88% of patients achieved PSA9069% achieved PSA90 in <90 days63% reached PSA <0.2 ng/mL
After 15.2 months, median time to PSA progression and radiographic progression-free survival haven't been reached, suggesting durable responses. The combination's tolerability and efficacy compare favorably to historical enzalutamide monotherapy data. This could potentially address resistance mechanisms in mCRPC, offering a new treatment paradigm.
The masofaniten-enzalutamide combination shows impressive PSA responses in mCRPC patients, including those previously treated with chemotherapy. The rapid and deep PSA reductions (
ESSA Pharma's masofaniten shows strong potential in the lucrative mCRPC market. The combination therapy's efficacy and safety profile could position it as a competitive option against existing treatments. Key financial implications:
- Potential for expanded market share in mCRPC treatment
- Possible accelerated regulatory pathway given promising Phase 1/2 results
- Increased investor interest may boost ESSA's stock (NASDAQ: EPIX)
The ongoing Phase 2 expansion study across multiple countries indicates significant investment in the drug's development. If successful, masofaniten could become a major revenue driver for ESSA Pharma, potentially transforming the company's financial outlook.
Combination of masofaniten plus enzalutamide continues to be well tolerated with durable reductions in PSA in patients with mCRPC
Phase 2 dose expansion currently underway at the RP2CDs of masofaniten 600 mg BID in combination with enzalutamide 160 mg QD
Across all dosing cohorts,
"We are pleased to be sharing more mature data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide today at ESMO 2024. The combination continues to be well tolerated with prolonged reductions in circulating prostate-specific antigen ("PSA") levels in patients with metastatic castration-resistant prostate cancer ("mCRPC"). After 15.2 months of follow up, neither median time to PSA progression nor radiographic progression free survival have been reached. These data compare favorably to historical data for single agent enzalutamide treatment in the mCRPC patient population," said David Parkinson, MD, President and CEO of ESSA. "We continue to focus on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 33 sites activated in the US, Canada and Australia and an additional 22 sites anticipated in Europe. We look forward to providing further updates in 2025."
Poster presentation details:
Title: Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared with Enz alone in subjects with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 results and Phase 2 design
Presenting Author: Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center
Presentation #: 1641P
Date and time: Sunday, September 15, 2024; 12:00-1:30 p.m. CEST/ 6:00-7:30 a.m. ET
Data summary: This Phase 1/2 multicenter, open-label clinical trial enrolled patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today includes 18 patients across four cohorts in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.
In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 32 cycles of dosing in some patients. Most frequent adverse events were Grades 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related, resulting in the expansion of the cohort from four to seven patients. No additional dose-limiting toxicities (DLTs) were observed, therefore the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 combination doses (RP2CDs) were identified as masofaniten 600 mg twice daily (BID) in combination with enzalutamide 160 mg once daily (QD).
In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). Across all dose cohorts,
The randomized, open-label, two arm, Phase 2 dose expansion portion of the study is underway and is designed to evaluate the combination of masofaniten and enzalutamide versus single agent enzalutamide in patients with mCRPC naïve to second generation anti-androgens. The study is currently enrolling at approximately 33 sites in the
About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com, and follow us on X and LinkedIn.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding presentations with respect to the Phase 1/2 study, the tolerability of masofaniten in combination with enzalutamide, PSA reductions resulting from masofaniten in combination with enzalutamide, the potential long-term benefits of masofaniten, providing future updates on the Phase 1/2 and Phase 2 studies, the timing of and enrollment in the Company's studies and other statements surrounding the Company's evaluation of masofaniten.
Forward-looking statements are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions.
Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA's Annual Report on Form 10-K dated December 12, 2023, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca, and as otherwise disclosed from time to time on ESSA's EDGAR and SEDAR+ profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable
Contacts
ESSA Pharma, Inc.
Peter Virsik, Chief Operating Officer
778.331.0962
pvirsik@essapharma.com
Investors and Media:
Argot Partners
212.600.1902
essa@argotpartners.com
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