The American Society of Clinical Oncology (ASCO) Annual Meeting (“ASCO 22”) took place this year from June 2nd through the 6th, 2022. During this Annual Meeting, stakeholders within the oncology field discussed new advances in cancer research, real-time insights, and more. According to a news release, researchers from pharmaceutical company Daiichi Sankyo and clinical research organization the Sarah Cannon Research Institute presented data from a Phase 1 clinical trial. In their presentation (Abstract #3002), the researchers discussed early results from the Phase 1 clinical trial evaluating DS-6000 for advanced renal cell carcinoma (RCC) and ovarian cancer. If successful, and given additional future research, DS-6000 could fill an unmet need for patients who progress after given other therapeutic options.
What is DS-6000?
In the description for the Phase 1 clinical trial, DS-6000 is described as:
an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of DS-6000 into the cells. MAAA-1181a that is released from DS-6000 in the target cells inhibits cell replication and induces cell apoptosis.
Currently, DS-6000 is considered to be an investigational treatment. It was developed using proprietary DXd ADC technology. Currently, there are no cancer therapeutics which use CDH6 direction. Therefore, if DS-6000 is shown to be efficacious, it could be the first therapy of its kind.
Altogether, approximately 102 patients with either advanced ovarian cancer or RCC will be enrolled within this clinical study. The study will consist of two main parts: the first of which establishes safety and tolerability in relation to escalating doses, and the second of which explores the safety and efficacy of 8.0 mg/kg DS-6000. During the first portion of the study, researchers will also determine a recommended dose for further studies.
So far, 30 patients have been enrolled in the study. Of these, 70% have pre-treated ovarian cancer and 30% have RCC. Additionally, 85% of those with ovarian cancer had platinum-resistant ovarian cancer. It is imperative to find novel therapies for patients with advanced ovarian cancer and RCC, as these conditions have poor 5-year survival rates. Thus, a new treatment option could not only fill an unmet need, but potentially greatly improve outcomes.
Primary study results show that DS-6000 is relatively safe, effective, and well-tolerated. 12 individuals with platinum-resistant ovarian cancer experienced disease stability on DS-6000. Additionally, 25% of those with ovarian cancer and 5% of those with RCC saw partial treatment responses. 9.6 mg/kg DS-6000 was found to be a slightly higher dose than needed; one patient discontinued due to adverse reactions at this dose. Otherwise, DS-600 was relatively well-tolerated, with common side effects being nausea and vomiting, appetite loss, fatigue, and diarrhea.
About Ovarian Cancer
As the name suggests, ovarian cancer forms in the ovaries, almond-shaped organs which store eggs and produce hormones. Ovarian cancer may form in one or both ovaries. There are four main types of ovarian cancer: epithelial tumors, germ cell carcinoma tumors, stromal carcinoma tumors, and small cell carcinoma of the ovary. In many cases, doctors are unsure what causes ovarian cancer. However, women with BRCA gene mutations are 10-30x more likely to develop ovarian cancer than others. Symptoms can include abdominal pain and bloating, pelvic pain, appetite loss, changes in urinary urgency or frequency, menstrual irregularities, breast tenderness, or abnormal bleeding or vaginal secretions.
About Renal Cell Carcinoma (RCC)
PRC, TFE 3, and VHL gene mutations have all been associated with renal cell carcinoma (RCC), an easily metastasizing kidney cancer. However, researchers believe that other factors could also cause or increase the risk of developing RCC, such as smoking cigarettes or having a history of kidney problems. RCC is considered to be a rare cancer, though it is also considered the most common form of adult-onset kidney cancer. It is more common in males between ages 50-70. Symptoms of RCC can include fatigue, fever, enlarged testicles, abdominal pain, hematuria (blood in the urine), and unintended weight loss.