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Photocure Partner Asieris to present First-ever Results of the international multicenter Phase III clinical Study for Cevira, a non-surgical treatment for cervical HSIL, at the 2024 EUROGIN
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Photocure Partner Asieris to Unveil Results of the international multicenter Phase III clinical Study for Cevira, a non-surgical treatment for cervical HSIL, at the 2024 SGO
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Photocure Partner Asieris announces positive international Phase III clinical trial results for Cevira and data presentations at the 2024 EUROGIN Congress and SGO Annual Meeting
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Her er fra Asieris:
Breakthrough in Treatment of Cervical High-Grade Squamous Intraepithelial Lesion: Release of Positive Results from Multicenter Phase III Global Clinical Study
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The world’s first non-surgical cervical HSIL treatment validated by an international Phase III clinical study with proven efficacy;
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The response rate increased by 89.4% compared to the placebo control group, with a low incidence of adverse events;
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The China new drug application submission is expected in Q2 2024, while ex-China product development is in active progress.
Shanghai, China, March 18, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases announced that the multicenter Phase III global clinical study data of its non-surgical treatment for cervical HSIL product APL-1702 demonstrated significant efficacy and good safety profile, with new advancements in clearance rate of high-risk HPV16 and/or HPV18. Key data from the study were presented in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting.
APL-1702 is a pioneering cold light photodynamic drug-device combination product，used as a non-surgical therapy for treating cervical HSIL. This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Response is defined as the conversion of cervical epithelial tissue pathology to normal or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance.
According to the study results, between November 2020 and July 2022, a total of 402 eligible patients from various countries including China, Germany, the Netherlands et al. were randomized and enrolled in this study. The response rate in the APL-1702 treatment group showed a statistically significant improvement of 89.4% (41.1% vs. 21.7%, p = 0.0001) compared to that in the placebo control group， indicating a remarkable therapeutic effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 treatment group compared to the control group (31.4% vs. 15.4%)1. The incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment group and the control group, with the majority being mild and self-healing without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were both low in both groups2.
According to the “Global Cancer Statistics 2020” report, there were 604,127 new cases of cervical cancer in women worldwide in 2020, with 341,831 deaths, ranking it as the fourth most common cancer among women. Cervical cancer incidence ranks second among malignant tumors in Chinese women. According to the “National Cancer Report 2024” released by the National Cancer Center, there were 150,700 new cases of cervical cancer in China in 2022, with 55,700 deaths from cervical cancer.
The main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years3 . According to Frost Sullivan analysis, it is projected that by 2030, the number of HSIL patients worldwide and in China will reach 16.6 million and 2.2 million, respectively. With the increasing popularity of dual-cancer screening and cervical cytology tests, more and more patients with cervical precancerous lesions are being detected at early stages before cancer develops, and it is expected that the number of patients will continue to increase.
Women with cervical precancerous lesions have unmet clinical needs for non-surgical therapies. Currently, invasive procedures such as loop electrosurgical excision procedure (LEEP) and cold knife conization remain the primary treatment options for high-grade cervical lesions. However, these surgical treatments are associated with adverse reactions including bleeding, infection, and cervical structural damage, which may lead to complications such as preterm birth and miscarriage. Furthermore, cervical precancerous lesions require long-term monitoring and management because even after surgical treatment, there is a risk of persistent disease or recurrence, with a higher risk of developing cervical cancer compared to the general population (5 times higher risk of invasive cancer within 10 years). Therefore, post-operative follow-up for at least 25 years is necessary. Importantly, if cervical precancerous lesions recur, subsequent surgical interventions become more challenging and carry higher risks, potentially resulting in total hysterectomy. Thus, early surgical intervention increases the difficulty of long-term management. Non-surgical therapies that preserve the intact cervix and avoid or delay cervical trauma are of significant importance for the long-term management of patients with cervical precancerous lesions.
Professor Chen Fei, Chief Physician of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital, expressed her delight with the research findings, stating, “I am extremely pleased with the results of this study. Treating HSIL serves as the final barrier against cervical cancer. Previous international studies on HSIL have not been successful, but this study, utilizing a multicenter trial design and strict definition of efficacy endpoints, has achieved positive results, which is no easy feat. As a clinician, I have encountered many HSIL patients who desire to preserve their intact cervix while receiving treatment. The emergence of APL-1702 will fulfill the wishes of these patients, allowing them to avoid or delay cervical trauma to the maximum extent possible.”
Professor Qiao Youlin, a member of the WHO Global Expert Group for Cervical Cancer Elimination and a professor at the School of Population Medicine and Public Health at the Chinese Academy of Medical Sciences/Peking Union Medical College, believes that in addition to vaccination and screening, treatment of cervical precancerous lesions is a crucial component of secondary prevention for cervical cancer. However, progress in the field of medication for cervical precancerous lesions has been relatively slow, with high barriers to overcome, and there are currently no approved treatment drugs worldwide. “It is gratifying to see the emergence of innovative products like APL-1702, which simultaneously possess clinical value in addressing the treatment gap, public health value in cervical cancer prevention and control, and social value in promoting fertility-friendly options. This breakthrough will safeguard women’s health and make a positive contribution to the acceleration of the 2030 global and Chinese action plans for cervical cancer elimination”.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, “We are extremely proud of the results from the international multicenter Phase III clinical study of APL-1702. The study not only demonstrates remarkable efficacy but also exhibits a favorable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. We express our gratitude to all the patients, physicians, and researchers who participated in this study, as their support and dedication have been invaluable. We are actively preparing the new drug application for APL-1702 and plan to submit it in the second quarter of this year. Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible.”
References：
- EUROGIN: Photodynamic therapy with APL-1702 for high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study (YHGT-CEV-1/APRICITY)
- SGO: APL-1702 long-term efficacy and safety for cervical histologic high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study
- 高蜀君,隋龙.子宫颈高级别鳞状上皮内病变的规范化处理及随访[J].中国实用妇科与产科杂志. 2020,36(07):604-608.
About APL-1702(Cevira®)
APL-1702(Cevira ® ) is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira ® holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira ® in July 2019. Cevira ® is a registered trademark of Photocure ASA, based in Oslo, Norway.
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Gitt det man vet om ambisjonene/behovet Kina har for å gjøre noe med fertilitetsutfordringene, så er det interessant å se hva slags terreng Asieris med ambassadører som dette beveger seg i. For min del tilsier det at PHO vil kunne oppleve at Asieris sikrer seg globale rettigheter (noe de har gjort tidligere) og/eller at selskapet rett og slett kjøpes opp. Kina er også et sted der ting kan gå relativt raskt om først en “løsning” på et problem blir tilgjengelig.
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(Asieris har allerede kjøpt de globale rettighetene for produktet.)
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Trodde de kun hadde Asia/Kina, takk for oppklaring.
utdrag:
“The benefit of a therapy like this is that it is low risk, it’s office-based, it doesn’t need anesthesia, had very limited treatment-related adverse events that were quite manageable, and doesn’t require any anatomic disruption of the cervix, which could have an impact on fertility, cervical stenosis, and pelvic pain,” noted SGO discussant Kristin Bixel, MD, of the Ohio State University Comprehensive Cancer Center in Columbus.
However, Bixel questioned whether placebo was an appropriate control arm, and noted that an excisional procedure or ablation would be appropriate for patients over the age of 25. She also said long-term outcomes with APL-1702, as well as patient experience, compared with other appropriate or indicated procedures should be evaluated.
“Additionally, it would be important to consider the cost of this device, especially if retreatment is frequently indicated,” she added.
Wang explained that while low-grade squamous intraepithelial lesions (LSIL) usually resolves spontaneously, guidelines for cervical cancer screening generally recommend medical treatment for women with HSIL – surgical treatments that could result in complications for women of reproductive age.
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Wang and colleagues also conducted analyses of 216 HSIL patients in the APL-1702 group with 6-month efficacy data who entered the open-label extension of the study.
Based on results from the extension population, Wang reported that responses with APL-1702 were durable:
- Of 102 patients who responded at 6 months, 54.9% maintained response until 12 months after first treatment
- 40% of patients who had LSIL histology and non-clearance of baseline HPV at 6 months became responders at 12 months
- The overall response rate at 12 months was 44.4% – 58.3% of patients had maintained response and 41.7% were new responders
Wang also noted that among the entire study population, the proportion of patients treated with APL-1702 who were HPV-positive at baseline fell to 82.1% at 3 months, 64.8% at 6 months, and 41.4% at 12 months. There was a trend of increasing HPV clearance over time, and up to 12 months.
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Canadian Health Authorities approve updated and expanded label for Cysview
Oslo, Norway, March 22, 2024: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces the reception of the Note of Compliance from Health Canada this week, approving the updated Product Monograph for Cysview® in Canada.
The updated indication now covers non-muscle invasive bladder cancer in general, including detection of carcinoma in situ (CIS), a very aggressive form of bladder tumor that is difficult to detect because of its flat shape.
The indication now reads:
“CYSVIEW (hexaminolevulinate hydrochloride) is indicated for:
As an adjunct to white-light cystoscopy in the diagnosis and follow up of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with known or suspected bladder cancer to increase tumor detection.”
In addition, there has been a confirmation of the safe use of Cysview, by update of the safety sections of the Product Monograph, and a clarification that no safety risk has been identified by repeated use of Cysview.
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Norsk:
Ny publikasjon: Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy
Pressemelding – Oslo, Norge, 28. mars 2024: Photocure ASA, The Bladder Cancer Company, kunngjør publiseringen av studien «Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry» i tidsskriftet Cancers denne uka. Denne studien tar sikte på å evaluere heterogenitet i egenskaper ved blått lys cystoskopi (BLC®) for påvisning av ondartede lesjoner blant ulike raser med ikke-muskelinvasiv blærekreft (NMIBC).
Studieforfatteren Sia Daneshmand, MD og deltakerne i BLC med Cysview Study Group samlet inn klinikopatologisk informasjon fra voksne pasienter som gjennomgikk transurethral reseksjon av blæretumor (TURBT) eller biopsi som ble registrert i det multiinstitusjonelle BLC Cysview-registeret mellom april 2014 og februar 2021. Det primære resultatet var påvisning av enhver ondartet lesjon ved endelig patologi. Sensitivitet, negative og positive prediktive verdier for påvisning av ondartede lesjoner ble beregnet for BLC, hvitt lys cystoskopi (WLC) og kombinasjonen av begge modaliteter.
Totalt ble det identifisert 2379 separate prøver fra 1292 pasienter, hvorav 1095 (85 %) var hvite/kaukasiske, 96 (7 %) svarte/afroamerikanere, 51 (4 %) asiatiske og 50 (4 %) latinamerikanske. Sensitiviteten til WLC, BLC og kombinasjonen av begge for enhver malign lesjon var henholdsvis 88,7 %, 95,8 % og 99 % i den totale kohorten (P<0,001). BLC-sensitivitet vs. WLC var mest signifikant uttalt i den asiatiske befolkningen (96 % vs 78 %, P<0,001). I alle raser var sensitiviteten til BLC signifikant høyere enn WLC for påvisning av CIS (P<0,001). I tillegg økte tillegget av BLC til standard WLC deteksjonsraten med 10 % for enhver ondartet lesjon i hele kohorten. Denne frekvensen økte til 18 % hos asiatiske pasienter. Positiv prediktiv verdi av BLC var også den høyeste i asiatisk befolkning (94,4 %).
Forfatterne konkluderer med at uavhengig av rase, økte BLC påvisningen av blærekreft når kombinert med WLC. Forskjellen var imidlertid mer uttalt hos asiatiske pasienter: «Vår studie viste at uavhengig av rase, øker BLC oppdagelsen av blærekreft når det kombineres med WLC. Disse resultatene kan identifisere forskjeller i grupper som vil føre til forbedret behandling av undertjente minoritetspopulasjoner. Ytterligere forskning er berettiget for å forstå den underliggende etiologien til disse observasjonene som til slutt kan endre tolkningen av lesjoner oppdaget av BLC,” sa Dr. Daneshmand.
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Verdt å ta med seg for Asieris, dette.
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Asieris Pharmaceuticals to Present the Drug and Equipment Performance Results from the Phase III Clinical Study of the Bladder Cancer Diagnostic and Management Drug APL-1706 in Combination with HD 4K Blue Light Cystoscopy
Shanghai, China, April 1, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, will unveiled the drug and equipment performance results from the Phase III clinical study of its bladder cancer diagnostic and management drug APL-1706 in combination with HD 4K blue light cystoscopy at the 39th Annual Meeting of the European Association of Urology (EAU) on April 5-8, 2024, in Paris. in the form of an oral presentation.
Abstract ID ：A1032
Date： April 8, 2024
Abstract Title : A prospective, comparative, within-patient controlled multicenter phase III study comparing blue light cystoscopy in combination with APL-1706 versus white light cystoscopy for the detection of bladder cancer using modern HD 4K equipment
Professor Hu Hailong from Tianjin Medical University Second Hospital will be the speaker.
The new drug application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 2023.
EAU 2024: Photocure Partner Asieris to present the Drug and Equipment Performance Results from the Chinese Phase III Clinical Study of Hexvix in Combination with HD 4K Blue Light Cystoscopy equipment
PUBLISHED: 1 APRIL 2024
MEDICAL CONGRESSES & EVENTS
MEDICAL INFORMATION
PARTNERSHIP NEWS & EXPANSION
Oslo, Norway, April 1, 2024: Photocure ASA, The Bladder Cancer Company, announces that its partner Asieris plans to unveil the drug and equipment performance results from the Phase III clinical study of Hexvix (bladder cancer diagnostic and management drug - APL-1706) in combination with HD 4K blue light cystoscopy equipment at the 39th Annual Meeting of the European Association of Urology (EAU), April 5-8, 2024 in Paris. The oral abstract presentation is scheduled for April 8.
Abstract Title: A prospective, comparative, within-patient controlled multicenter phase III study comparing blue light cystoscopy in combination with APL-1706 versus white light cystoscopy for the detection of bladder cancer using modern HD 4K equipment
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Muntlig fremføring 8. April 
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European Association of Urology (EAU) 2024 congress features new data on modern technology use in bladder cancer care
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Ser ikke ut for at noen bryr seg om denne meldingen, fagpressen eller finans pressen. Resultatet er likevel enestående;
The BLC detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while the WLC detection rates were NA, 42.1%, 76.1%, 91.2%, and 100%. This study confirms the superiority of HAL BLC over WLC in the detection of bladder cancer even if improved WLC using HD 4K equipment is utilized. In particular, additional high-risk difficult to see CIS lesions have been identified in 85% of all CIS patients only by HAL BLC. The quality of resection is still a key cornerstone in the treatment of NMIBC of which BLC remains a crucial part despite the further development of WLC imaging.
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