Krystal Biotech Shows Early Monotherapy Effect in Advanced NSCLC Patients

Krystal Biotech, Inc., a leading biotechnology firm, recently declared initial clinical findings from its KYANITE-1 study, which is examining the effects of inhaled KB707 on patients with solid lung tumors. This innovative therapeutic approach involves delivering the treatment directly through inhalation, showcasing promising results, particularly in individuals with advanced non-small cell lung cancer (NSCLC).

As of the latest data update on December 6, 2024, the study revealed that inhaled KB707 as a standalone treatment achieved a 27% objective response rate (ORR) and a 73% disease control rate (DCR) among NSCLC patients. These figures are significant, especially for patients who have already exhausted standard treatment options, offering them new hope.

Dr. Wen Wee Ma, an expert on cancer therapeutics, highlighted the innovative approach of the treatment, which maximizes efficacy while minimizing systemic toxicity. The KYANITE-1 trial, which is currently underway, is an open-label, multicenter study focusing on dose escalation and expansion. It explores two dosage levels, 108 PFU and 109 PFU of KB707, with the latter chosen for further study. Treatment frequency involves weekly inhalations for the initial three weeks, followed by one every three weeks, aiming to evaluate safety, tolerability, and tumor responsiveness.

Since the trial commenced on April 17, 2024, a total of 37 participants have received at least one dose of KB707, with 17 diagnosed with advanced NSCLC. These patients, all presenting with lung malignant lesions, have shown good tolerance to the treatment, which is suitable for outpatient settings. The adverse events observed have mostly been mild to moderate, aligning with expectations based on the disease and the known profiles of interleukin-2 and interleukin-12.

The clinical activity observed thus far is most notable in patients with advanced NSCLC. Among 11 assessable patients, the ORR was 27%, with three partial responses recorded, and a DCR of 73%, indicating continued treatment success. The duration of these treatments ranged from 10.3 to 33.3 weeks. Particularly noteworthy are the responses in lung lesions, where a 36% ORR, including three partial and one complete response, and an 82% DCR were recorded.

Suma Krishnan, Krystal Biotech’s President of Research and Development, expressed excitement about these findings, emphasizing the potential of their vectorized cytokine approach in tackling challenging cancers. These results contribute to a growing pool of clinical data, reinforcing the capability of their HSV-1 platform to deliver genetic material effectively to the lungs, impacting disease progression.

Encouraged by the initial outcomes, Krystal Biotech has amended the KYANITE-1 protocol to include two new cohorts evaluating the combination of inhaled KB707 with anti-programmed cell death protein 1 (PD-1) therapy, and another combining it with both PD-1 therapy and chemotherapy. Enrollment for these new cohorts is yet to commence.

Krystal Biotech plans to share more detailed and updated results from the KYANITE-1 study at upcoming scientific conferences, further advancing their research and development in genetic medicines targeting unmet medical needs in various diseases.