Medivir's fostrox + Lenvima confirm promise of improved outcomes in advanced liver cancer, detailed and mature data presented at ESMO
Medivir AB presented positive, mature data from its ongoing phase 1b/2a study of fostroxacitabine bralpamide (fostrox) + Lenvima® in advanced liver cancer at the ESMO Congress. Key findings include:
- Median time to progression (TTP) of 10.9 months
- Objective response rate (ORR) of 24%
- Median duration of response of 7.0 months
- 19% of patients continuing treatment for over a year
- Longest running patient on treatment for over 2 years
The safety profile remains encouraging, with no unexpected adverse events. Fostrox, an orally-administered, liver-targeted inhibitor of DNA replication, shows promise in improving outcomes for second-line liver cancer patients when combined with Lenvima.
Medivir AB ha presentato dati positivi e maturi dal suo studio in corso di fase 1b/2a su fostroxacitabine bralpamide (fostrox) + Lenvima® nel cancro avanzato al fegato durante il Congresso ESMO. I principali risultati includono:
- Tempo mediano di progressione (TTP) di 10,9 mesi
- Percentuale di risposta obiettiva (ORR) del 24%
- Durata mediana della risposta di 7,0 mesi
- 19% dei pazienti in trattamento da oltre un anno
- Paziente con il trattamento più lungo da oltre 2 anni
Il profilo di sicurezza rimane incoraggiante, senza eventi avversi inaspettati. Fostrox, un inibitore della replicazione del DNA somministrato per via orale e mirato al fegato, mostra promesse nel migliorare i risultati per i pazienti con cancro al fegato di seconda linea quando combinato con Lenvima.
Medivir AB presentó datos positivos y maduros de su estudio en curso de fase 1b/2a sobre fostroxacitabina bralpamida (fostrox) + Lenvima® en cáncer de hígado avanzado en el Congreso de ESMO. Los hallazgos clave incluyen:
- Tiempo medio hasta la progresión (TTP) de 10,9 meses
- Tasa de respuesta objetiva (ORR) del 24%
- Duración media de la respuesta de 7,0 meses
- 19% de los pacientes que continúan el tratamiento por más de un año
- Paciente que lleva en tratamiento más de 2 años
El perfil de seguridad sigue siendo alentador, sin eventos adversos inesperados. Fostrox, un inhibidor de la replicación del ADN administrado por vía oral y dirigido al hígado, muestra promesas para mejorar los resultados en pacientes con cáncer de hígado de segunda línea cuando se combina con Lenvima.
메디비어 AB는 ESMO 회의에서 긍정적이고 성숙한 데이터를 발표했습니다. 이는 포스트록사시타빈 브랄파미드 (포스트록) + 렌비마®의 진행 중인 1b/2a 단계 연구에서 얻은 데이터로, 고급 간암 환자에 대한 것입니다. 주요 발견 사항은 다음과 같습니다:
- 중간 진행 시간 (TTP) 10.9개월
- 객관적 반응률 (ORR) 24%
- 반응의 중간 지속 기간 7.0개월
- 1년 이상 치료를 지속한 환자 19%
- 2년 이상 치료를 받은 환자
안전성 프로필은 예기치 않은 부작용 없이 고무적입니다. 포스트록은 경구 투여되는 간 표적 DNA 복제 억제제로, 렌비마와 함께 사용할 때 2차 간암 환자의 결과를 개선하는 데 가능성을 보여줍니다.
Medivir AB a présenté des données positives et matures lors de son étude en cours de phase 1b/2a sur fostroxacitabine bralpamide (fostrox) + Lenvima® dans le cadre du cancer du foie avancé lors du congrès ESMO. Les résultats clés comprennent :
- Temps médian avant progression (TTP) de 10,9 mois
- Taux de réponse objective (ORR) de 24%
- Durée médiane de la réponse de 7,0 mois
- 19 % des patients poursuivant le traitement depuis plus d'un an
- Patient le plus ancien en traitement depuis plus de 2 ans
Le profil de sécurité reste encourageant, sans événements indésirables inattendus. Fostrox, un inhibiteur de la réplication de l'ADN administré par voie orale et ciblant le foie, montre des promesses pour améliorer les résultats chez les patients atteints de cancer du foie de deuxième ligne en association avec Lenvima.
Medivir AB präsentierte positive, ausgereifte Daten aus seiner laufenden Phase 1b/2a-Studie zu Fostroxacitabine Bralpamide (Fostrox) + Lenvima® bei fortgeschrittenem Leberkrebs auf dem ESMO-Kongress. Die wichtigsten Ergebnisse umfassen:
- Medianzeit bis zur Progression (TTP) von 10,9 Monaten
- Objektive Ansprechrate (ORR) von 24%
- Median der Ansprechdauer von 7,0 Monaten
- 19% der Patienten, die mehr als ein Jahr in Behandlung sind
- Längster Patient in Behandlung seit über 2 Jahren
Das Sicherheitsprofil bleibt ermutigend, ohne unerwartete unerwünschte Ereignisse. Fostrox, ein oral verabreichter, leberspezifischer Inhibitor der DNA-Replikation, zeigt vielversprechende Aussichten zur Verbesserung der Ergebnisse für Patienten mit sekündärem Leberkrebs in Kombination mit Lenvima.
- Median time to progression (TTP) of 10.9 months, substantially longer than typical 3-4 months in second-line HCC
- Objective response rate (ORR) of 24%, compared to 5-10% with current standard of care
- 19% of patients continuing treatment for over a year, with longest patient on treatment for over 2 years
- Promising duration of benefit with median duration of response of 7.0 months
- Patients benefited from treatment regardless of previous therapy outcomes
- Favorable safety profile allowing long-term treatment combination
- None.
Insights
The mature data from Medivir's phase 1b/2a trial of fostrox + Lenvima in advanced liver cancer shows promising results. The median time to progression of 10.9 months is substantially longer than the typical 3-4 months seen with current second-line treatments. The
The safety profile is particularly noteworthy. Despite combining two potent treatments, the tolerability allows for long-term use, with
The data suggests potential benefit for all second-line patients, regardless of their response to previous therapy. This could significantly expand the eligible patient population if confirmed in larger trials.
As an oncologist, I find the results of the fostrox + Lenvima combination in advanced HCC quite promising. The 10.9-month median time to progression is a significant improvement over current second-line options. What's particularly intriguing is the durability of response, with some patients maintaining benefits for over two years.
The safety profile is reassuring. While hematological adverse events were common, their cyclical nature allowed for recovery between treatments, enabling long-term therapy. The absence of febrile neutropenia and serious bleeding events is important for maintaining quality of life in these patients.
The potential for this combination to benefit patients regardless of their response to first-line therapy is a game-changer. If confirmed in larger trials, it could provide a valuable option for a broader range of HCC patients, addressing a significant unmet need in second-line treatment after immunotherapy.
From a market perspective, Medivir's fostrox + Lenvima combination shows significant potential in the lucrative HCC market. With approximately 660,000 new HCC cases diagnosed annually and a 5-year survival rate below
The combination's efficacy and safety profile could position it as a strong contender in this space. The long duration of treatment benefit observed could translate to extended drug usage and potentially higher revenues per patient. Moreover, the combination's effectiveness across different patient subgroups could expand its market reach.
However, it's important to note that these results are from a phase 1b/2a trial. The upcoming phase 2b study comparing fostrox + Lenvima with Lenvima alone will be critical in confirming these benefits and determining the combination's market potential. If successful, it could significantly impact Medivir's market position in oncology.
- Mature results from Medivir's phase 1b / 2a open label trial of fostrox + Lenvima® confirm improved outcomes in second-line advanced liver cancer with a median time to progression (TTP) of 10.9 months1 (4.1 – 18.1).
- The results showed an objective response (ORR) of
24% , and a median duration of response of 7.0 months. - Detailed safety update reinforces the ability to combine fostrox and Lenvima long-term, only 1 patient discontinuing fostrox due to adverse events.
- Medivir's fostrox (fostroxacitabine bralpamide) is the only orally-administered, liver-targeted inhibitor of DNA replication. Its unique mechanism for the treatment of liver cancer delivers the cell-killing compound selectively to tumor cells locally in the liver while minimizing harm to healthy cells.
Today's ESMO update, poster number 986P, presented by Dr Hong Jae Chon on Monday September 16, shows promising duration of benefit with
Results come despite very poor prognosis for most second-line HCC patients today, with just 5–
Dr. Pia Baumann, Chief Medical Officer at Medivir, said:
- "With three patients still remaining on study treatment, all of whom treated for more than a year, this data-set is now quite mature. At a median follow-up of 10.5 months, fostrox + Lenvima have clearly shown promise of improved outcomes beyond current alternatives for second-line liver cancer patients. Fostrox is designed to only target tumor cells locally in the liver, without harming healthy cells. It is therefore reassuring to see the tolerability profile of fostrox enabling the combination of two highly potent treatments, fostrox + Lenvima, without compromising patient safety. Patients were able to stay on treatment long-term, which evidently contributes to the extended duration of benefit and a median time to progression of 10.9 months, substantially longer than previously seen in second-line liver cancer. It is with reinforced confidence we continue our preparations for the initiation of the planned phase 2b study comparing fostrox + Lenvima with Lenvima alone in a randomized setting to confirm the benefit of the combination."
Dr Hong Jae Chon, Professor at CHA Bundang Hospital in
"Treatment outcomes have improved in first-line with the use of immunotherapy combinations, resulting in more patients fit enough to receive second-line treatment. But with no treatments approved in second-line after immunotherapy, there is a significant unmet medical need for new treatments options for these patients. The phase 1b/2a data for fostrox + Lenvima show highly encouraging clinical benefits for patients, indicating that when adding fostrox to Lenvima, efficacy is better than expected from Lenvima alone. It is especially encouraging that in addition to patients experiencing benefit for an extended period of time, patients also responded to the treatment independent of outcome in previous line of therapy. I look forward to evaluating the efficacy of fostrox plus Lenvima in a randomized, controlled trial."
The data are from Medivir's ongoing phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.
HCC is the most common type of liver cancer, accounting for more than
Medivir will host a webcast where Dr Chon and Dr Pia Baumann will present the data and answer questions. The webcast will take place Today, September 16, at 13.45 CET, and will be streamed via a link on the website: www.medivir.com/investors/presentations.
The poster and the presentation from the webcast will also be available on Medivir's website after the presentation.
For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: magnus.christensen@medivir.com
About fostrox
Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile.
About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the
About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a drug candidate designed to selectively treat cancer cells in the liver and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.
- Data cut-off 19 August, 2024
- Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118.
- Yang, J.D.,
Hainaut , P., Gores, G.J. et al. A global view of hepatocellular carcinoma: trends, risk, prevention and management. Nat Rev Gastroenterol Hepatol 16, 589–604 (2019).
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FAQ
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