1stOncology™: Cancer Intelligence Service – Page 64 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Moleculin Reports Independent Assessment Confirms No Cardiotoxicity of Annamycin in 90 Subjects

On January 13, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported it has received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin, bringing the total number of Annamycin treated subjects reviewed by its independent expert to 90. Data from the most recently completed clinical trials’ subjects were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of certain data, the independent expert concluded that there was no evidence of cardiotoxicity. This data is across five clinical trials treating acute myeloid leukemia (AML) and soft tissue sarcoma (STS) with Annamycin as a monotherapy and in combination with cytarabine and across multiple sites in the United States (US) and the European Union (EU). Most of these subjects were treated above the recommended lifetime maximum for other anthracyclines.

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!

The data made available to the expert included, but was not limited to, data from serial 12-lead ECGs, transthoracic echocardiography with centralized global longitudinal strain (GLS) analysis, and cardiac biomarker (troponins I and T) concentration measurements by a central lab using validated assays. Cardiac health biomarkers such as blood troponin levels are considered an indicator of potential long-term heart damage.

"As we closely approach almost 100 subjects that have received Annamycin (also known by the name "naxtarubicin") which have been reviewed by our expert, we continue to be encouraged by the potential of Annamycin. This additional independent report of additional datasets provides further validation of the absence of cardiotoxicity," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Annamycin continues to demonstrate an absence of cardiotoxicity, even in subjects who have received far more than the lifetime maximum cumulative anthracycline exposure established by the US Food and Drug Administration (FDA). In fact, 65 of the 90 subjects evaluated have been taken over the FDA’s lifetime maximum of 550 mg/m2 and with one of them being taken over 6500 mg/m2. Our growing body of positive data for Annamycin continues to bolster our confidence in our belief that Annamycin is truly a ‘next generation’ anthracycline, especially in light of the growing efficacy data that we have previously reported in the treatment of AML and STS. We remain focused on advancing our Annamycin development programs and ultimately, addressing the medical unmet needs of people with difficult to treat cancers."

"It is important to understand that nearly half of all cancers and 60% of childhood cancers are currently treated with cardiotoxic anthracyclines that result in permanent damage to the heart. To quote one study: ‘Some commonly used cancer drugs, such as the anthracyclines, are known to be cardiotoxic. Left undetected and untreated, this cardiotoxicity is progressive and persistent and can lead to cardiomyopathy, clinical heart failure, the need for a heart transplant, or death. In fact, 30 years after diagnosis, the number of cardiac-related deaths among survivors exceeds the number caused by cancer recurrence (emphasis added).’ We believe Annamycin has the potential to become the first ever non-cardiotoxic anthracycline. Coupled with its observed ability in a wide range of tumor animal models to avoid cross-resistance with existing anthracyclines and to demonstrate equal or greater efficacy, we believe the market opportunity for Annamycin is potentially enormous. We are looking forward to adding to this dataset and completing long-term cardiac follow-up with active subjects in our current trials."

(Press release, Moleculin, JAN 13, 2026, https://moleculin.com/moleculin-reports-independent-assessment-confirms-no-cardiotoxicity-of-annamycin-in-90-subjects/ [SID1234662017])

TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue and 2026 Revenue Guidance and Anticipated Development Milestones

On January 13, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics), reported preliminary U.S. net product revenue for BRIUMVI for the fourth quarter and full year ended December 31, 2025 (unaudited), as well as 2026 financial guidance and development milestones, during a preannounced presentation at the 44th Annual J.P Morgan Healthcare Conference. An audio replay of the event, as well as the corresponding slide presentation, are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events.

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, "BRIUMVI continued to deliver strong commercial performance in 2025, reinforcing our confidence in the multi-billion dollar opportunity for BRIUMVI. With significant market share capture since launch, we believe TG Therapeutics is well positioned to drive long-term revenue growth and cash flow. Additionally, our development programs for consolidated IV BRIUMVI dosing and self-administered subcutaneous form of BRIUMVI are expected to drive revenue acceleration over the short and mid-term if approved. In parallel, we plan to initiate multiple exploratory studies that could expand BRIUMVI beyond MS, providing an additional lever for growth and underscoring its potential as a ‘pipeline-in-a-product.’ We also remain excited about the potential of azer-cel, our allogeneic CAR-T in autoimmune indications, starting with progressive forms of MS. Taken together, we believe we are executing a strategy designed to deliver sustained growth and long-term value for patients and shareholders."

Preliminary Fourth Quarter and Full Year 2025 Updates (based on unaudited financial information)

●

BRIUMVI U.S. net product revenue expected to be approximately $182 million and $594 million for the fourth quarter and full year of 2025, respectively

●

Total global full year 2025 revenue of approximately $616 million

●

Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results.

2026 Financial Guidance

●

Full Year 2026 target total global revenue of approximately $875-900 million, including BRIUMVI U.S. net product revenue of approximately $825-850 million

●

Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 million excluding non-cash compensation, and approximately $100 million in expenses associated with the subcutaneous BRIUMVI inventory build and secondary manufacturer start-up costs

2026 Development Pipeline Anticipated Milestones

●

Announce pivotal topline data for ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI mid-year 2026

●

Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026

●

Announce pivotal topline data for subcutaneous BRIUMVI (ublituximab) year-end 2026/1Q 2027

●

Commence registration-directed trial for BRIUMVI in an indication outside of MS

●

Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS)

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

●

Active Hepatitis B Virus infection

●

A history of life-threatening infusion reaction to BRIUMVI

WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

(Press release, TG Therapeutics, JAN 13, 2026, View Source [SID1234662016])

Labcorp Expands MRD Testing for Breast, Lung and Colon Cancer Recurrence Risk

On January 13, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported the continued expansion of its molecular residual disease (MRD)i portfolio designed to help clinicians detect cancer recurrence earlier than traditional imaging. The expanded offerings include Labcorp Plasma Detect ID, a whole exome sequence-guided, personalized panel for patients with stage I–III breast cancer or stage I–IIIA non-small cell lung cancer, and the nationwide availability of Labcorp Plasma Detect Genome, a whole-genome MRD test for stage III colon cancer.

Despite advancements in treatment, cancer recurrence rates remain a significant concern for patients and clinicians. Approximately 35% of stage III colon cancer patients will experience recurrence after treatment, along with 10% to 40% of patients with stage I-III breast cancer, and 10% to 55% of patients with stage I–III non-small cell lung cancer.

MRD testing helps clinicians track a patient’s risk of cancer recurrence by detecting small traces of circulating tumor DNA (ctDNA) in a patient’s bloodstream following treatment. This can signal molecular recurrence months before clinical relapse appears on traditional imaging or causes symptoms. Both Labcorp Plasma Detect ID and Labcorp Plasma Detect Genome MRD tests can detect ctDNA down to a limit of detection (LOD95) of 0.005%. Earlier detection allows oncologists to tailor surveillance strategies and helps inform next steps, offering patients greater clarity during a critical period of uncertainty.

"For patients who have completed cancer treatment with curative intent, ongoing monitoring is essential to understand their risk of recurrence," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "By expanding the Labcorp Plasma Detect portfolio, we’re giving clinicians advanced tools to track molecular residual disease and detect recurrence risk earlier, supporting more personalized and proactive care, while increasing patient access to non-invasive testing options."

Labcorp has several ongoing and completed clinical studies that highlight the clinical utility of Labcorp Plasma Detect to track early disease progression, predict long-term outcomes, and identify residual cancer. Two peer-reviewed publications recently featured clinical studies of Labcorp Plasma Detect that focus on the test’s utility in patients diagnosed with diffuse pleural mesothelioma and head and neck cancer, adding to a growing body of research that supports MRD testing as a critical component of personalized cancer care. In addition, data were presented at the recent AMP 2025 Annual Meeting outlining the continued development of Labcorp Plasma Detect Genome MRD.

The expanded Labcorp Plasma Detect portfolio builds on Labcorp’s leadership in oncology diagnostics, supporting cancer care from screening and risk assessment, through diagnosis and prognosis, therapy selection and monitoring and surveillance. Through a full spectrum of clinical and oncology tests, including liquid biopsy, tissue-based comprehensive genomic profiling, and companion diagnostics, Labcorp partners with oncologists, health systems and biopharma companies to drive precision medicine, improving outcomes and expanding access for patients globally.

(Press release, LabCorp, JAN 13, 2026, View Source [SID1234662015])

U.S. FDA grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in first line unfit Acute Myeloid Leukemia

On January 13, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. IPN60340 is an investigational first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer. Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. IPN60340 previously received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

"This Breakthrough Therapy Designation recognizes both the urgent need for new treatment options for people living with acute myeloid leukemia and the promising data seen so far in the development program for IPN60340," said Christelle Huguet, PhD, EVP and Head of R&D, Ipsen. "We look forward to working closely with the FDA as we advance to the next stage of clinical development and continue to deliver medicines with the potential to be transformative to people living with cancer."

This Breakthrough Therapy Designation is based on data from the Phase I/II EVICTION trial. Updated clinical data orally presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) (n=57)1 from the EVICTION trial showed treatment with IPN60340 in combination with Ven-Aza achieved very encouraging high responses. In this single-arm trial, treatment with IPN60340 and Ven-Aza (n=38), resulted in a near doubling of the complete response relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).1,2 IPN60340 in combination with Ven-Aza was also shown to be well tolerated, underscoring IPN60340’s potential as a novel immunotherapy to improve outcomes for patients with AML. Based on these preliminary data, we look forward to discussing the design of the Phase II/III development plans with the FDA for IPN60340 in H1 2026.

About the EVICTION trial

EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of IPN60340 (ICT01) in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About IPN60340 (ICT01)

IPN60340 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by IPN60340 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, IPN60340 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of IPN60340 have been shown in patients across several cancer indications. IPN60340 is an investigational therapy under evaluation for people 75 years or older living with acute myeloid leukemia who due to comorbidities are prevented from receiving treatment with intensive chemotherapy.

(Press release, Ipsen, JAN 13, 2026, View Source [SID1234662014])

ImmunityBio Announces Positive Results Demonstrating ANKTIVA® as a Lymphocyte Stimulating Agent in Combination With Checkpoint Inhibitors in Non-Small Cell Lung Cancer

On January 13, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported positive results from its ANKTIVA (nogapendekin alfa inbakicept) clinical program in non-small cell lung cancer (NSCLC) based on two studies, QUILT-2.023 and QUILT-3.055. Across 151 patients spanning first-, second-, and later-line disease, ANKTIVA demonstrated statistically significant immune restoration and a consistent association between lymphocyte recovery and improved survival in checkpoint-experienced patients.

Checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have transformed the treatment landscape for lung cancer; however, clinical benefit is often transient, and effective treatment options remain limited once patients progress following standard-of-care chemo-radiation and checkpoint inhibition.

QUILT-2.023 and QUILT-3.055 were designed to test the hypothesis that disease recurrence after checkpoint therapy reflects immune exhaustion and lymphocyte depletion, and that restoration of immune competence through activation of natural killer cells and CD8* cytotoxic T cells with ANKTIVA, in combination with checkpoint inhibitors, could improve outcomes.

"Today, the default standard of care for these patients remains cytotoxic chemotherapy such as docetaxel, which is associated with substantial toxicity and limited survival benefit," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "Large, randomized trials have demonstrated median overall survival of approximately nine months with docetaxel. The results from these studies support a potential paradigm shift toward what we define as Immunotherapy 2.0, which is the coordinated activation of the innate immune system through natural killer cells and the adaptive immune system through T cells to restore immune competence and extend survival."

Detailed results from QUILT-2.023 and QUILT-3.055 are being prepared for peer-review publication and future scientific presentations and serve as foundational safety and efficacy data demonstrating meaningful clinical benefit in patients with NSCLC who have failed all standards of care including checkpoint inhibitors.

The combination of ANKTIVA plus checkpoint inhibitor therapy is protected by multiple issued patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, with patent terms extending into 2032–2039.

About QUILT-2.023

QUILT-2.023 (NCT03520686) is a Phase 3, open-label, multicohort study evaluating ANKTIVA in combination with approved checkpoint inhibitor–based regimens as first-line treatment for patients with advanced or metastatic NSCLC. The study included three randomized cohorts and one exploratory cohort, each analyzed independently.

The primary randomized cohort enrolled patients with stage III or IV squamous or nonsquamous NSCLC with PD-L1 expression ≥1% and no prior systemic therapy for advanced disease. Patients were randomized 1:1 to CPI alone or CPI plus ANKTIVA. Stratification factors included CPI regimen, ECOG performance status, histology, and PD-L1 tumor proportion score. The primary endpoint was progression-free survival assessed by RECIST v1.1, with longitudinal absolute lymphocyte count prospectively incorporated as a key biological endpoint.

Enrollment was closed early following changes in the first-line NSCLC treatment landscape. All analyses were conducted according to the finalized protocol and statistical analysis plan.

About QUILT-3.055

QUILT-3.055 (NCT03228667) is a Phase 2b, multicohort, open-label study evaluating the addition of nogapendekin alfa inbakicept to continued PD-1/PD-L1 inhibitor therapy in patients with advanced solid tumors who progressed after prior checkpoint inhibition. The study enrolled heavily pretreated patients, including second- and later-line NSCLC.

Patients continued the same checkpoint inhibitor to which they had previously responded or stabilized, with ANKTIVA administered subcutaneously in repeated six-week cycles. The primary objective prospectively linked immune biology to clinical outcomes by evaluating overall survival in relation to absolute lymphocyte count response, defined as achieving or maintaining a mean on-treatment ALC ≥1,000 cells/µL. Secondary endpoints included objective response rate, progression-free survival, duration of therapy, and safety.

(Press release, ImmunityBio, JAN 13, 2026, View Source [SID1234662013])