1stOncology™: Cancer Intelligence Service – Page 1088 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Iovance Biotherapeutics Highlights Strong Fourth Quarter and Full Year 2025 Results, Business Achievements and Corporate Updates

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance delivered approximately 30 percent quarterly revenue growth and achieved our 2025 guidance range in the first full calendar year of launch. Growth was driven by increasing demand for Amtagvi. After ongoing improvements in our operations and gross margin, we are well positioned for future profitability. Iovance is poised to create substantial value for patients and shareholders as we increase revenue while advancing our registrational trial in non-small cell lung cancer and best-in-class TIL pipeline in solid tumors."

Fourth Quarter and Full Year 2025 Financial Highlights
Topline Growth, Significant Margin Improvement, and Cost Optimization

Fourth quarter 2025 total product revenue of ~$87 million with strong growth of ~30% over the prior quarter, including:
U.S. Amtagvi revenue of ~$65 million.
Global Proleukin revenue of ~$22 million.
Fourth quarter 2025 gross margin from cost of sales was ~50%, reflecting increasing benefits from solid execution and cost optimization.
Full year 2025 total product revenue of ~$264 million achieved the guidance range of $250 million to $300 million in the first full year of launch, including:
U.S. Amtagvi revenue of ~$220 million.
Global Proleukin revenue of ~$44 million.
The cash position as of December 31, 2025 of ~$303 million1 is expected to fund operations into the third quarter of 2027.
Operational excellence initiatives, including internalization of all lifileucel manufacturing and optimization of research and development activities, are expected to drive significant additional improvements in operating expenses, cost of sales and gross margin in 2026 and 2027.
Amtagvi Commercial Launch
Strong U.S. Commercial Growth and Execution with Approvals Pending in New Global Markets

Best-in-class Amtagvi real-world response rates are increasing adoption and strengthening referral trends toward earlier treatment.
An oral presentation at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) reported:
An unprecedented overall objective response rate (ORR) of ~44%.
Higher ORR of 52% after two or fewer prior lines of therapy, highlighting the importance of early treatment.
A continuously growing and maturing network of U.S. authorized treatment centers (ATCs) expanded patient access in 2025, with further acceleration anticipated in 2026.
Academic ATCs are contributing to growth as new centers onboard and experienced centers treat more patients.
The first community ATCs began treating patients in late 2025 and are expected to drive additional demand in 2026.
A specialty pharmacy distribution channel was introduced as another option for ATCs to purchase Amtagvi.
Five-year analysis of the C-144-01 trial of Amtagvi demonstrated ~31% ORR, median duration of response (mDOR) of 36+ months, and ~20% five-year overall survival, highlighting the unprecedented long-term benefits of this first-in-class therapy.
Manufacturing turnaround improved to 32 days or less from inbound to return shipment to ATCs.
Global expansion of Amtagvi is underway in several markets outside the U.S.
Amtagvi was approved in Canada in August 2025.
Regulatory submissions are under review with potential approvals in the United Kingdom and Australia in the first half of 2026, and Switzerland in the first half of 2027.
Iovance is working with the European Medicines Agency (EMA) to resubmit a marketing authorization application (MAA) in 2026.
Lifileucel in Previously Treated Advanced NSCLC: IOV-LUN-202 Registrational Trial
Clinical and Regulatory Momentum Building Towards Potential 2H27 Launch

The U.S. FDA granted Fast Track Designation (FTD) for lifileucel for the treatment of adults with metastatic nonsquamous (NSQ) NSCLC that has progressed on or after chemo- and anti-PD-1 therapies and at least one line of FDA-approved targeted therapy, if indicated, for actionable tumor mutations excluding ALK, ROS1 and EGFR.
Positive interim data demonstrated a potential best-in-class profile in NSQ advanced NSCLC patients.
The ORR was 26% and mDOR was not reached at 25+ months of follow up following one-time lifileucel monotherapy.
Standard of care docetaxel has shown 12.8% ORR, 5.6 months mDOR, and 12.3 months overall survival, highlighting a significant unmet medical need.2
Anticipated milestones:
Present updated data at a major medical meeting in 2026.
Complete enrollment in 2026.
Support a supplemental Biologics License Application for U.S. accelerated approval with a potential launch in the second half of 2027.
Pipeline Updates
New Data Across Several Pipeline Programs Anticipated Throughout 2026

Iovance announced positive early data for one-time lifileucel treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy:
Among the first six evaluable patients, the confirmed RECIST v1.1 ORR was 50%.
Iovance plans to commence a single arm registrational trial in previously treated advanced UPS and DDLPS in the second quarter of 2026 and engage with the FDA on a path to expedited approval.
The Phase 3 TILVANCE-301 trial of lifileucel and pembrolizumab in frontline advanced melanoma made significant progress, with enrollment accelerating across a broad and expanding global footprint. The U.S. FDA previously granted FTD in frontline advanced melanoma for lifileucel in combination with pembrolizumab. The TILVANCE-301 trial is designed with FDA and EMA input to show contribution of components for lifileucel in combination with pembrolizumab compared to pembrolizumab alone.
Two of Iovance’s Phase 2 trials, IOV-END-201 and IOV-MEL-202, are investigating lifileucel in previously treated patients with advanced endometrial cancer and melanoma, respectively.
A Phase 1/2 trial is investigating IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC.
A Phase 1/2 trial is investigating IOV-3001, a second-generation, modified IL-2 analog for use in the TIL treatment regimen.
An Investigational New Drug (IND) submission is planned in the first half of 2026 to begin clinical development of IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, in a Phase 1/2 basket trial.
Multiple investigator-sponsored clinical trials are exploring new solid tumor indications for Iovance TIL therapies and next generation approaches.
Webcast and Conference Call

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.

(Press release, Iovance Biotherapeutics, FEB 24, 2026, View Source [SID1234662918])

Iovance Announces Positive Results from the First Clinical Trial for TIL Cell Therapy in Soft Tissue Sarcomas

On February 24, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported positive early data from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy.

Among the first six evaluable patients treated with lifileucel monotherapy, physician-assessed confirmed ORR by RECIST v1.1 was 50%. All evaluable patients had advanced disease, were refractory to prior therapy, and had significant disease burden, with a mean sum of diameters of 117 millimeters at baseline and a mean of more than two prior lines of therapy. Patients experienced deep responses that improved over time, consistent with lifileucel in melanoma, non-small-cell lung cancer, and other solid tumors. The safety profile was favorable and consistent with lifileucel therapy in other indications. Based on these results, Iovance plans to commence a single arm registrational trial in second-line advanced UPS and DDLPS in the second quarter of 2026 and will engage with the U.S. Food and Drug Administration (FDA) on an accelerated path to expedite approval. Iovance also plans to explore lifileucel in other high grade soft tissue sarcoma subtypes with high unmet need as part of its clinical development program.

UPS and DDLPS are high grade, aggressive soft tissue sarcomas associated with poor prognosis that impact more than 3,000 patients in the U.S. and more than 5,000 patients in Europe annually, including more than 3,500 patients with advanced disease.1-3 There is a high unmet medical need for new treatment options for second-line patients with recent clinical studies reporting ORRs of less than 5%, median progression-free survival (mPFS) of ~2-3 months, and median overall survival (mOS) of ~9-10 months.4-6

Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist, MSKCC, stated, "In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with lifileucel demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care. Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026."

Dr. Brian Gastman, EVP Translational Medicine and Research at Iovance, stated, "The exciting clinical results show that lifileucel could offer a new, highly efficacious, and durable immunotherapy option in two aggressive forms of advanced sarcoma and further illustrate the promise of our TIL cell therapy platform to offer meaningful clinical benefit in multiple solid tumor cancers. Chemotherapy with extremely poor efficacy remains the second-line standard of care for these patients after progression on front-line chemotherapy. We look forward to bringing lifileucel to UPS and DDPLS patients as quickly as possible."

(Press release, Iovance Biotherapeutics, FEB 24, 2026, View Source [SID1234662917])

Intellia Therapeutics to Participate in Upcoming Investor Conferences

On February 24, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported that management will be participating in the upcoming investor conferences:

TD Cowen 46th Annual Health Care Conference
Date: Tuesday, March 3, 2026
Fireside Chat Time: 1:10 p.m. ET
Location: Boston, MA
Leerink Global Healthcare Conference
Date: Monday, March 9, 2026
Fireside Chat Time: 8:40 a.m. ET
Location: Miami, FL
Barclays 28th Annual Global Healthcare Conference
Date: Tuesday, March 10, 2026
Location: Miami, FL

The fireside chats on March 3 and March 9 will be webcast live. To join the webcasts, please visit the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com. Replays of the webcasts will be available on this same page for approximately 90 days following the events.

(Press release, Intellia, FEB 24, 2026, View Source [SID1234662916])

IN8bio to Present at TD Cowen 46th Annual Health Care Conference

On February 24, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, reported that William Ho, CEO and co-founder, will be presenting at the TD Cowen 46th Annual Health Care Conference on Monday, March 2, at 9:50 am ET.

William Ho will be giving a company presentation highlighting IN8bio’s latest achievements and upcoming milestones. The conference, to be held March 2-4, 2026, in Boston, will also include one-on-one investor meetings hosted by members of management.

A live webcast and replay link for the TD Cowen conference can be found here, and will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

(Press release, In8bio, FEB 24, 2026, View Source [SID1234662915])

Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026

On February 24, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, including two corresponding posters.

The AACR (Free AACR Whitepaper) 2026 conference will be held from April 17-22, 2026. The AACR (Free AACR Whitepaper) plans to publish the abstract titles on March 17, 2026 at 4:30 pm EST, the abstracts on April 17, 2026 at 3:00 pm EST, and the posters on the date of the presentation at the conference.

CEO Snehal Patel commented, "One of these abstracts will be the first abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01."

About the AACR (Free AACR Whitepaper) Annual Meeting 2026

The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR (Free AACR Whitepaper) Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, FEB 24, 2026, View Source [SID1234662913])