World Ovarian Cancer Day and the important of clinical development

Ovarian cancer is one of the most lethal gynecologic malignancies worldwide, often diagnosed at an advanced stage due to subtle or non-specific symptoms. Despite being relatively less common than other cancers, its high mortality rate makes it a major public health concern.

Global Statistics (as of latest data)

Incidence: ~313,000 new cases globally per year.
Mortality: ~207,000 deaths annually.
5-Year Survival Rate: Varies by stage and region; global average ~45%.
Higher incidence in developed countries (e.g., Europe, North America).
Higher mortality-to-incidence ratio in low-income countries due to limited access to care.

Etiology and Risk Factors

Risk Factor	Detail
Age	Risk increases after age 50
Family history/BRCA genes	BRCA1/BRCA2 mutations significantly increase risk
Reproductive history	No childbirth, late menopause, early menstruation
Hormonal factors	HRT (hormone replacement therapy)
Lifestyle factors	Obesity, high-fat diet, smoking
Endometriosis	Linked to certain subtypes (e.g., clear cell)

Tumor types include:

Epithelial tumors which are aggressive and are the most common representing 90% of cases.
Germ cell tumors are more common in younger women
Stromal tumors are rare and are hormone-producing tumors.

Current Approved Treatment Modalities include:

Surgery: Debulking (removal of as much tumor as possible)
Chemotherapy: Platinum-based agents (e.g., carboplatin, paclitaxel)
Targeted therapies like:
- PARP inhibitors (mutation dependent)
- Monoclonal antibodies
- Immunotherapy

Diagnosis and Survival

Diagnosis remains a challenge for several reasons. Income, access to healthcare and cultural stigmas around gynecological health remain factors in both diagnosis and treatment rates. Lack of effective screening tools coupled with vague symptoms (bloating, pelvic pain, fatigue) often result in diagnosis occurring at Stage III or IV, where spread beyond ovaries has occurred. Late diagnosis and scarce treatment options impede survival rates.

WHO & FIGO efforts for gynecologic oncology training seek to improve diagnosis and treatment outcomes through education. Awareness days like World Ovarian Cancer Day (May 8) aim to both inform and garner interest in this important topic.

Importance of Clinical Development

Ovarian Cancer Research Alliance (OCRA) and Globe-athon and other public and private initiatives provide funding for education, research and patient support.

Recent advances due to clinical research include understanding the benefits of genomic profiling in personalizing treatment plans, targeted therapies including PARP inhibitors and cell therapies, advancements in liquid biopsy allowing for non-invasive diagnosis and disease monitoring and utilizing Artificial intelligence to assist in outcomes and recurrent predictions.

Aixial Case Study Summary

Design: Randomized, stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy
Product: engineered autologous tumor cells
Sites: 65 sites (USA)
Patients: 385 patients-enrollment complete, LTFU in progress
Successes:
- Interactions with NExTRAC and IBCs.
- Timely site activations
- Planning patient enrollment around manufacturing room availability.
- Aixial team was heavily relied upon by the Sponsor to act in the best interests of the study due to developing commercial trial experience.
Challenges with mitigations:
- High screen failure rate specific to a sponsor relationship site rectified by an intelligent contract restructure and protocol retraining
- Mix up of patient tumor tissue at a site. Study wide retraining completed with videos posted for referencing and focused on diligent tumor handling and logistics management.
- IP capping issue with vial caps cracking or exploding during product thaw. Rapid issue resolution included testing and applying new caps while instructing sites to thaw under hood or wearing masks while new cap tested and then deployed.tise to accelerate approval timelines

About Aixial Group

Since 1999, Aixial have performed more than 1,600 studies across the globe with our teams in APAC, Europe, and North America.
Aixial 1,000+ person team includes multiple oncology physicians and has extensive clinical research experience. Our team members average 15 years of direct support, management and delivery of clinical trials.
Aixial oncology expertise from 306 trials is summarized below. This portfolio includes high volume enrollment trials with aggressive start-up timelines.