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Krystal Biotech KRYS announced encouraging initial clinical data from an early to mid-stage study of its investigational immunotherapy candidate, KB707, to treat patients with solid tumors of the lung.
The phase I/II KYANITE-1 study is evaluating the safety, tolerability and tumor response (measured using RECIST v1.1 criteria) of inhaled KB707 as a monotherapy in 37 patients with malignant lesions in the lung. Out of the total enrolled patient population, 17 were diagnosed with advanced non-small cell lung cancer (NSCLC). Two doses of KB707 (108 PFU or 109 PFU) were evaluated during the dose-escalation phase of the KYANITE-1 study, following which 109 PFU was selected for dose expansion.
Results showed that patients treated with inhaled KB707 demonstrated early evidence of monotherapy activity with the most therapeutic benefit observed in advanced NSCLC patients, who have progressed after standard-of-care treatments.
In the past three months, shares of Krystal Biotech have lost 14.9% compared with the industry’s 13.3% decline.
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More on KRYS’Development of KB707 for Lung Cancer
Out of the 17 NSCLC patients treated with inhaled KB707 in Krystal Biotech’s KYANITE-1 study, 11 were evaluable for response with at least one radiographic scan and RECIST v1.1 evaluation as of data cut-off on Dec. 6, 2024.
The analyzed patients had undergone extensive treatment, with a median of four prior therapy lines, including at least one immunotherapy. In this NSCLC cohort, an overall response rate (ORR) of 27% was observed, with three partial responses. The disease control rate (DCR) reached 73%, with seven out of 11 patients continuing treatment. Treatment durations ranged from 10.3 to 33.3 weeks as of the data cut-off.
Additionally, Krystal Biotech reported that treatment with inhaled KB707 showed promising results outside the lungs, with notable responses in lung lesions. Among the 11 evaluable NSCLC patients, the ORR in target lung lesions specifically was 36%, including three partial responses and one complete response, while DCR was 82%. Despite being early, management believes that the observed monotherapy activity with inhaled KB707 supports the potential of KRYS’ HSV-1 platform to safely and repeatedly deliver functional genetic material to the lung and impact the course of the disease.
Encouraged by positive initial monotherapy results, Krystal Biotech has updated the KYANITE-1 protocol to include two new cohorts studying inhaled KB707 in combination with anti-PD-1 therapy alone or with chemotherapy for advanced NSCLC. Patient enrollment in these combination cohorts has not yet begun. The company expects to disclose detailed and updated results of KYANITE-1 at future medical conferences.