RE: RNS16 Jan 2025 07:03
Clinical data observations:
Out of 10 patients with SGC treated at the dose of 250 mg/m2 and above, 5 patients experienced clinically meaningful disease shrinkage, including a confirmed partial response (PR, 45% tumor shrinkage) and four minor responses (MR, 10-19.5% tumor shrinkage) using RECIST criteria.1 These data include the following cases:
· A durable, confirmed PR was observed at 12 weeks in a 79-year-old male patient. The response is ongoing despite patient discontinuation due to reaching lifetime maximum of doxorubicin exposure. This patient began their treatment with AVA6000 in October 2023 following one line of therapy which he experienced disease progression prior to enrolling in the AVA6000 clinical trial.
· Rapid and complete regression of large skin and visceral metastasis was observed in a 74-year-old male patient experiencing a MR, despite low to mid-level FAP expression in the cancer-associated fibroblasts alone. A 15% reduction in parotid and lymph nodal lesions continues at the12 weeks post scan. This patient began treatment in September 2024 following two prior lines of therapy to which he experienced disease progression with both therapies prior to enrolling in the AVA6000 trial.
Although these data are reported early in the treatment course of most patients, it is notable that six patients (of the 10 patients with SGC), including all five responders, remain on treatment and a further two patients remain in progression-free follow-up after having received the maximum number of cycles of AVA6000. Only one patient has reported disease progression as best response resulting in the disease control rate of 90% in this group of patients with salivary gland cancers.
Treatment with AVA6000 continues to be well-tolerated in both dosing arms, once every two weeks (Q2W) and once every three weeks (Q3W), with reduced hematologic and cardiac toxicities compared to conventional dose doxorubicin at 75 mg/m2 dosed every 3 weeks. A maximum tolerated dose has not been identified in either arm of the trial.
1 Reduction in the sum of longest diameters (SLD) is used to measure response per RECIST 1.1 with partial responses having at least a 30% reduction and minor responses of between >10% and