Trial of BAT8006 for form of ovarian cancer doses 1st patient
Therapy may offer option for patients with platinum-resistant type
The first patient has been dosed in a Phase 3 trial testing the investigational therapy BAT8006 in people with platinum-resistant ovarian cancer, according to the treatment’s developer, Bio-Thera Solutions.
Early data from a Phase 1 trial have demonstrated the therapy’s tolerability and preliminary efficacy in this patient population, and the Phase 3 trial (CTR20251345) is expected to help establish those benefits.
“BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients,” Bio-Thera said in a company press release, noting that the therapy “may offer a novel therapeutic option for this difficult-to-treat population.
BAT8006 delivers chemotherapy agent directly to cancer cells
Platinum-based chemotherapy medications are commonly used along with surgery in the first-line treatment of ovarian cancer. But this form of gynecological cancer often becomes resistant to these drugs, and additional treatment options are limited.
BAT8006 is a type of targeted therapy called an antibody-drug conjugate that’s designed to deliver a chemotherapy agent directly to cancer cells while avoiding harm to the body’s healthy cells. It contains a chemotherapy agent called a topoisomerase I inhibitor, linked to an antibody that binds to the folate receptor (FR)-alpha protein.
FR-alpha is commonly found at high levels on the surface of cancer cells, including ovarian cancers. As such, the antibody serves to guide the chemotherapy drug specifically to the cancer cells.
Another FR-alpha-targeted medication called Elahere (mirvetuximab soravtansine) is already approved in the U.S. and elsewhere for people with difficult-to-treat ovarian cancer.
However, Elahere is restricted to the approximately 25% to 30% of people with platinum-resistant ovarian cancer whose tumors have high levels of FR-alpha (at least 75% expression). It also comes with eye-related toxicities, according to Bio-Thera.
Phase 1 trial results showed progression-free survival of nearly 8 months
A Phase 1 clinical trial (NCT05378737) was designed to evaluate BAT8006 in people with advanced solid tumors and to identify the recommended dose for future trials.
It included a first dose escalation part involving people with multiple types of advanced solid tumors, as well as a second dose expansion part involving people with platinum-resistant ovarian cancer who had FR-alpha expression levels of at least 1%.
Clinical data covering 133 people with platinum-resistant, epithelial ovarian, primary peritoneal, or fallopian tube cancer who participated in either trial part were presented at a recent conference. All of these participants received BAT8006 monotherapy, at various doses, given via into-the-vein, or intravenous, infusions once every three weeks.
The results showed progression-free survival — the time spent alive without cancer progression — was 7.63 months with BAT8006 treatment across all dose groups.
Disease control, where the cancer either remained stable or shrunk, was achieved by 80.5% of participants. The objective response rate (ORR), or the proportion of patients who achieved a partial or complete cancer shrinkage, was 40.7%.
[BAT8006] may benefit a broad patient population while providing a superior efficacy.
The researchers noted in the presentation that the promising efficacy of BAT8006 was observed regardless of patients’ FR-alpha expression levels, meaning the therapy “may benefit a broad patient population while providing a superior efficacy.”
BAT8006 also showed a favorable safety profile, with no cases of serious eye or lung toxicity. The most common treatment-related side effects included low blood cell counts.
The Phase 3 trial is now comparing the safety and efficacy of BAT8006 against standard-of-care chemotherapy in people with platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Other studies are investigating BAT8006 as part of combination treatment regimens. One is a Phase 1b/2 study that’s testing the safety and preliminary efficacy of BAT8006 when combined with BAT1308, another of Bio-Thera’s investigational therapies, in people with advanced solid tumors.
BAT1308 is an antibody designed to enhance the immune system’s ability to target and kill cancer cells.
Early data from participants with advanced ovarian and endometrial (uterine) cancers who had received two to six prior lines of therapy showed the therapy combination led to an ORR of 45.8%. A second part of that study is ongoing.
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