Breakthrough Clinical Results
Repare Therapeutics has entered into an exclusive worldwide licensing agreement with Debiopharm for lunresertib, a first-in-class PKMYT1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and future development activities. Repare will receive a $10 million upfront payment and is eligible for up to $257 million in potential milestones and royalties. This agreement allows Repare to focus on its ongoing Phase 1 trials for RP-1664 and RP-3467, with data expected in the second half of 2025. Lunresertib has shown promising results in clinical trials for solid tumors, and the combination with Debio 0123 (a WEE1 inhibitor) is believed to be highly synergistic.
Key Highlights
- Repare Therapeutics outlicenses lunresertib to Debiopharm for $10 million upfront and up to $257 million in potential milestones.
- Debiopharm will lead future development of lunresertib, including the MYTHIC study.
- Repare will focus on its Phase 1 trials for RP-1664 and RP-3467, with data expected in the second half of 2025.
- Lunresertib shows promise in treating difficult-to-treat solid tumors, particularly in combination with Debio 0123.
Incidence and Prevalence
Global Incidence and Prevalence of Solid Tumors
Worldwide cancer incidence and prevalence patterns vary significantly by cancer type, geographical region, and demographic factors. The available data shows substantial variations across different populations and tumor types.
In the United States, a total of 1,372,910 new cancer cases and 570,280 deaths were expected in 2005. Cancer has surpassed heart disease as the leading cause of death for persons younger than 85 since 1999. While cancer incidence rates stabilized in men from 1995 through 2001, they continued to increase by 0.3% per year from 1987 through 2001 in women.
When examining global patterns, a study of Indians residing in different geographic regions revealed the lowest total cancer incidence rates in India (111 and 116 per 100,000 among males and females, respectively) and the highest among US whites (362 and 296). Cancer incidence rates among Indians residing outside of India were intermediate: Singapore (102 and 132), UK (173 and 179) and US ranges 152-176 and 142-164.
Racial and ethnic disparities are evident in cancer statistics. African American men and women have 40% and 20% higher death rates from all cancers combined than White men and women, respectively. Other racial and ethnic groups generally have lower rates for all sites combined but higher rates for stomach, liver, and cervical cancers than Whites. Additionally, minority populations are more likely to be diagnosed with advanced stage disease.
For specific cancer types, esophageal cancer shows distinct patterns by histological type. The incidence of adenocarcinoma in White males has been rising (7.8%/year), with similar trends observed in White females, Hispanic males, and Hispanic females. Conversely, the incidence of squamous cell carcinoma has been steadily declining in White males and females and in Black females since 1973.
In Brandenburg (Germany), between 2000-2018, esophageal squamous cell carcinoma remained dominant but with a significant increase in adenocarcinoma in both sexes. The rate of new esophageal cancer cases was 5 times higher for men than for women.
For colorectal cancer, molecular differences in tumor mutation frequencies and gene expression may underlie observed differences by race and ethnicity. Increased African ancestry was associated with higher odds of somatic mutations in APC, KRAS, and PIK3CA and lower odds of BRAF mutations.
In Latvia, prostate cancer showed increasing standardized incidence rates from 18.9 per 100,000 in 1990 to 74.7 in 2012. Standardized prevalence rates increased from 69.9 per 100,000 in 1990 to 437.6 in 2012, while mortality rates rose from 13.2 per 100,000 in 1990 to 27.2 in 2006 followed by a statistically insignificant decrease continuing up to 2012.
Drug used in other indications
Lunresertib Clinical Trials Beyond Solid Tumors
Based on a thorough review of the available information, there is insufficient data to provide details about clinical trials of lunresertib (also known as XL413 or VIP152) for indications other than solid tumors.
The current clinical development program for this CDK9 inhibitor in indications beyond solid malignancies, including any hematological malignancies or other conditions, cannot be detailed at this time.
Similarly, specific information regarding the intervention models, dosing regimens, trial designs, or administration protocols used in these potential clinical studies is not available in the reviewed materials.
For the most current and accurate information about lunresertib's clinical development across various indications, it would be advisable to consult:
- Clinical trial registries such as ClinicalTrials.gov
- Scientific literature in peer-reviewed journals
- Conference proceedings from recent oncology meetings
- Corporate communications from the developing pharmaceutical company
Understanding the complete clinical development landscape for novel therapeutics like lunresertib requires access to the most recent research data and trial information.