Iovance Biotherapeutics(US:IOVA) Globenewswire·2025-11-03 12:00Core Insights - Iovance Biotherapeutics announced interim data from the Phase 2 IOV-LUN-202 trial of lifileucel monotherapy in previously treated advanced nonsquamous NSCLC, showing a 25.6% objective response rate (ORR) and a disease control rate of 71.8% [2][3][4] - The median duration of response (mDOR) was not reached after a median follow-up of 25.4 months, indicating potential long-term efficacy [3][4] - Lifileucel is expected to launch in the second half of 2027, following a supplemental Biologics License Application [4][7] Clinical Data - The trial reported an ORR of 25.6%, with 10 out of 39 patients showing an objective response, including 2 complete responses and 7 partial responses [3][5] - The safety profile of lifileucel was consistent with the underlying disease, showing improvements in overall safety without affecting efficacy [6][7] Regulatory and Market Context - The FDA provided positive feedback on the trial design, which aligns with guidance for accelerated approvals in conditions with unmet medical needs [4][5] - Current treatment options for advanced NSCLC are limited, with standard docetaxel monotherapy showing an ORR of only 12.8% and an mDOR of 5.6 months [5][6] Industry Background - Lung cancer is the most commonly diagnosed cancer globally, with approximately 2.5 million new cases and 1.8 million deaths each year [8][9] - Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, with nonsquamous NSCLC representing approximately 75% of those cases [9][10] Company Overview - Iovance Biotherapeutics focuses on developing tumor infiltrating lymphocyte (TIL) therapies, aiming to be a leader in this innovative treatment space [12][13] - The company is committed to continuous innovation in cell therapy, including gene-edited therapies, to improve patient outcomes [13]