Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant

On December 7, 2023 Sanofi reported that the Phase 3 IMROZ trial evaluating the investigational use of Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM) (Press release, Sanofi, DEC 7, 2023, View Source [SID1234638259]). This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care.

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Thierry Facon, MD
Professor of Haematology in the Department of Haematology, Lille University Hospital, Lille, France, member of French Academy of Medecine and IMROZ Principal Investigator

"The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies. First line therapeutic options are critical for all patients, but especially for those who are transplant-ineligible, given attrition rates in subsequent lines of therapy."

The safety and tolerability of Sarclisa observed in this trial was consistent with the established safety profile of Sarclisa and VRd.

Dietmar Berger, MD, PhD
Global Head of Development, Sanofi

"This is the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care, reinforcing our belief in Sarclisa as a best-in-class medicine. These data underscore our commitment to advancing scientific innovation for people living with multiple myeloma, and we look forward to sharing more detail on Sarclisa’s potential to improve outcomes for patients receiving earlier lines of therapy."

Study results will be submitted for presentation at an upcoming medical meeting and form the basis of a future regulatory submission.

About the IMROZ trial

The randomized, multi-center, open label Phase 3 IMROZ clinical trial enrolled 484 patients with newly diagnosed transplant-ineligible MM across 104 centers spanning 21 countries. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for five weeks during first 42-day cycle and once every two weeks in cycles 2 to 4 in combination with subcutaneous bortezomib, oral lenalidomide and intravenous or oral dexamethasone. Then Sarclisa was administered every 2 weeks from cycle 5 to 17 and every 4 weeks in cycles 18+ during 28-day cycles in combination with lenalidomide and dexamethasone at the standard dose, until disease progression, unacceptable safety profile or patient’s decision to stop the study treatment. The primary endpoint of IMROZ is progression-free survival. Key secondary endpoints include complete response rate, minimal residual disease negativity rate for patients with a complete response, very good partial response or better rate, overall survival. Other secondary endpoints are: overall response rate, time to progression, duration of response, time to first response, time to best response, progression-free survival on next line of therapy, progression-free survival by MRD status, sustained MRD negativity greater than or equal to 12 months rate, safety, pharmacokinetic profile, immunogenicity, disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status.1

The use of Sarclisa in combination with VRd in transplant-ineligible newly diagnosed MM is investigational and has not been fully evaluated by any regulatory authority.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in >50 countries, including the U.S. and EU, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the Phase 3 IKEMA study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the U.S. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies, and its safety and efficacy have not been evaluated by any regulatory authority outside of its approved indication.

For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov.

About multiple myeloma

MM is the second most common hematologic malignancy.2 Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma

On December 7, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Regeneron, DEC 7, 2023, View Source [SID1234638257]). These Phase 1/2 results are planned to be submitted to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) this year. Linvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

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"Multiple myeloma remains an incurable disease, in which patients endure cycles of relapse and remission, resulting in a critical need for innovative medicines," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. "With longer follow-up data on linvoseltamab, we’re seeing deep and durable responses with a complete response rate nearing 50% in a difficult-to-treat patient population who had received a median of 5 prior lines of therapy. Furthermore, in our trial, the regimen had a short monitoring time and a convenient, response-adapted administration schedule that enabled deep responders to go from every two-week to every four-week dosing. This regimen saved time for clinicians and patients, underscoring the potential for linvoseltamab as a patient-centric option in relapsed/refractory multiple myeloma."

At a median duration of follow-up of 11 months, an objective response rate of 71% as assessed by an independent review committee, with 46% achieving a complete response or better, was observed in patients treated with linvoseltamab 200 mg in the Phase 1/2 trial (n=117). After a minimum of 24 weeks of therapy, patients who achieved a very good partial response (VGPR) or better shifted from every two-week to every four-week dosing. These results build on an earlier data cut, with 8 months of median follow-up, that will be presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA.

Among this group of patients, 27% of patients were over 75 years old, 16% had extramedullary plasmacytomas, 23% had bone marrow plasma cells ≥50%, and 39% had high-risk cytogenetics – representing a patient population with a high disease burden and typically poor prognosis. Additionally, 17% were Black or African American, mirroring rates that are representative of MM in the U.S.

Based on the latest data cut, all patients treated with 200 mg experienced an adverse event (AE), including 85% who experienced Grade ≥3 adverse events (AE). The most commonly occurring AE was cytokine release syndrome (CRS; 46%). Of the CRS cases, the majority (35%) were Grade 1, 10% were Grade 2 and there was one case (1%) of Grade 3 CRS. Adjudicated immune effector cell-associated neurotoxicity syndrome (ICANS) events occurred in 9 patients (8% all Grades); Grade 3 ICANS occurred in 3 patients, and no cases of ≥Grade 4 cases. All grade infections were observed in 73% of patients; 34% were Grade 3 or 4. Deaths due to treatment-emergent AEs on-treatment or within 30 days post last dose occurred in 14 patients (12%), of which 11 (9%) were due to infections.

The development program investigating linvoseltamab, including in earlier stages of the disease is underway. In the U.S., linvoseltamab has been granted Fast Track Designation for multiple myeloma by the FDA. Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the company’s hematology portfolio on Thursday, December 14 at 8:30 AM ET. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

About the Phase 1/2 Trial
The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion trial is investigating linvoseltamab in patients with R/R MM. Among the 282 patients enrolled, all have received at least three prior lines of therapy or are triple refractory. Patients were administered linvoseltamab utilizing a step-up dosing regimen that was designed to help mitigate CRS.

The Phase 1 intravenous dose-escalation portion of the trial, which is now complete, primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab exploring different administration regimens. The Phase 2 dose expansion portion of the trial (LINKER-MM1) is further assessing the safety and anti-tumor activity of linvoseltamab, with a primary objective of ORR. Key secondary objectives include duration of response, PFS, rate of minimal residual disease negative status and overall survival.

About Multiple Myeloma
Multiple myeloma is the second most common blood cancer. Globally, there are over 176,000 new cases diagnosed annually and an estimated 35,000 people were diagnosed in the U.S. It is characterized by the proliferation of cancerous plasma cells (multiple myeloma cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Multiple myeloma is not curable despite treatment advances, and while current treatments are able to slow the progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

Regeneron to Share Progress of Novel Combination Therapies in Oncology at ESMO IO

On December 7, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the presentation of new and updated data on multiple combination therapies from its oncology pipeline at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023 from December 6 to 8 in Geneva, Switzerland (Press release, Regeneron, DEC 7, 2023, View Source [SID1234638255]). Highlights include first Phase 1 dose-escalation data for the investigational costimulatory bispecific antibody REGN5668 (MUC16xCD28) in combination with PD-1 inhibitor Libtayo (cemiplimab) showing encouraging initial activity in patients with recurrent ovarian cancer. Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).

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"Our ESMO (Free ESMO Whitepaper) IO presentations highlight the continued progress of Regeneron’s oncology pipeline, which was strategically curated to have the potential to offer novel and differentiated combinations targeting several types of difficult-to-treat cancers. We look forward to sharing first clinical data from our costimulatory bispecific program in patients with recurrent ovarian cancer, which is investigating a MUC16xCD28 bispecific antibody in combination with our PD-1 inhibitor Libtayo," said Israel Lowy, Senior Vice President, Translational and Clinical Oncology at Regeneron. "This is our second costimulatory bispecific program to report clinical data, with a total of four such agents currently in the clinic, and adds to the evidence showing that our novel CD28 costimulatory bispecifics can potentially enhance the anti-tumor activity of anti-PD-1 therapies in a synergistic fashion. Studies are also underway exploring the combination of CD28 costimulatory bispecifics with CD3 bispecifics, including REGN5668 with ubamatamab, our MUC16xCD3 bispecific."

Per initial results to be shared at ESMO (Free ESMO Whitepaper) IO, a combination of REGN5668 with Libtayo showed early clinical activity in patients with recurrent ovarian cancer. The trial enrolled 28 platinum-experienced patients with recurrent ovarian cancer, who received infusions of REGN5668 once-weekly at a dose range of 0.3-300 mg, with the addition of Libtayo infusions every three weeks beginning between day 21 and 28. At the time of initial data cut off (July 14, 2023), 6 patients (21%) had stable disease, while 1 patient (in the 300 mg REGN5668 cohort) had an ongoing confirmed partial response with a 59% target lesion reduction from baseline. Dose escalation is ongoing and has included administration of REGN5668 doses beyond 300 mg in combination with Libtayo.

The combination of REGN5668 and Libtayo demonstrated an acceptable safety profile in 28 patients with fatigue (32%), nausea (29%) and pain (18%) as the most common treatment-related adverse events (TRAEs). Infusion-related reactions occurred in 7% of patients and cytokine release syndrome occurred in 11% of patients and were all grade 1 or 2. There was one instance of a TRAE that was grade 3, which was fatigue. As of data cut off, there were no dose-limiting toxicities or adverse events resulting in death or treatment discontinuation. Dose escalation is continuing in order to define an optimal dose for expansion cohorts.

Regeneron presentations at ESMO (Free ESMO Whitepaper) IO:

Medicine(s) Abstract Title Abstract Lead Author Presentation date/time (all CET)

Libtayo, REGN5668 REGN5668 (MUC16xCD28 bispecific antibody) with cemiplimab (anti-PD-1 antibody) in recurrent ovarian cancer: Phase 1 dose-escalation study #127P John L. Hayes, M.D., Ph.D. Thursday, December 7, 2023; 12PM–1PM CET

Libtayo, chemotherapy Patient-reported outcomes (PROs) of cemiplimab + chemotherapy in advanced non-small cell lung cancer (NSCLC): EMPOWER-lung 3 liver metastases subpopulation #783P Ana Baramidze, M.D., Ph.D. Thursday, December 7, 2023; 12PM–1PM CET

Libtayo, SBRT Low-dose stereotactic body radiotherapy prior to pre-operative cemiplimab for patients with resectable hepatocellular carcinoma #LBA4 Thomas Marron, M.D., Ph.D. Thursday, December 7, 9:25AM–9:30AM CET
The potential uses of Libtayo and REGN5668 described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. REGN5668 is not currently approved for use in any indication.

PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress 2023

On December 7, 2023 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported a poster presentation with results from the Phase 1 portion of the Phase 1/2 dose escalation and expansion clinical trial of LYT-200 at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2023 (Press release, PureTech Health, DEC 7, 2023, View Source [SID1234638254]). LYT-200 is an anti-galectin-9 antibody being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene, in metastatic solid tumors, including urothelial and head and neck cancers. LYT-200 is also in development for the treatment of hematological malignancies, such as acute myeloid leukemia.

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The data being presented from an ongoing study including all evaluable patients demonstrate that LYT-200 has a favorable safety profile in all cohorts, including the monotherapy and combination arms, and shows disease control and initial anti-tumor activity in combination with tislelizumab. In the combination cohort, anti-tumor activity was observed in patients with relapsed or refractory head and neck squamous cell carcinoma, a patient population that has historically demonstrated a low response rate to anti-PD-1 agents of around 20 percent and 10 percent with chemotherapy.

"Galectin-9 is thought to play a foundational role in suppressing immune-mediated activity against tumor cells, and increases in galectin-9 expression have been shown to correlate with aggressive disease and higher mortality, as is seen in patients with head and neck and urothelial cancers," said Julie Krop, M.D., Chief Medical Officer at PureTech Health. "LYT-200 is the most advanced clinical program against this target, and we are very encouraged by the initial results and look forward to completing this study and advancing this program into late-stage development."

The Phase 1/2 clinical trial includes a dose finding/dose escalation phase (part 1) and an expansion cohort phase (part 2) in patients with relapsed and refractory, locally advanced/metastatic solid tumors. In the monotherapy cohort, 20 patients received LYT-200 across seven escalation doses, with dose levels of 0.2 mg/kg to 16 mg/kg once every two weeks or 10 mg/kg once a week. LYT-200 was well-tolerated with no observed dose-limiting toxicities and only low-grade adverse events, as well as long-term disease stabilization exceeding one year in patients with heavily pre-treated pancreatic cancer and in one patient with colorectal cancer. The monotherapy arm of the trial has been completed, and the clinically relevant dose was selected for the Phase 2 portion of the trial.

In the combination arm, 11 patients have been dosed, and the initial subset of all evaluable patients treated so far includes four patients with head and neck cancers and two patients with urothelial cancer. In the evaluable patients with head and neck cancers, disease control was observed in three of the four patients, with one patient experiencing a complete response for nine months, one patient with a deepening partial response for eight months, and one patient with disease stabilization for four months, and treatment in these patients remains ongoing. The two evaluable patients with urothelial cancer experienced disease stabilization for seven months and three months, and both remain on treatment. The combination arm continues to enroll patients with urothelial and head and neck cancers.

"Galectin-9 is a promising target for the treatment of solid tumors, and the initial results from the LYT-200 Phase 1 trial support its clinical potential," said Zev Wainberg, M.D., Professor of Medicine at UCLA and Co-director of the UCLA GI Oncology Program, and the lead primary investigator of the study.

The poster titled "Phase 1/2 Trial of Galectin-9 Antibody LYT-200 +/- Tislelizumab" will be presented today at The ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2023, which is taking place in Geneva, Switzerland.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of metastatic/locally advanced solid tumors, including urothelial and head and neck cancers, with otherwise poor survival rates. A wide variety of preclinical data supports the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found that in several cancers that galectin-9 levels correlate with shorter time to disease relapse and poor survival. Preclinical work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200 in multiple animal and patient-derived tumor cell models. For example, LYT-200 outperforms anti-PD-1 in preclinical models as a single agent. LYT-200 also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in cancer in vivo models. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial for the potential treatment of advanced solid tumors and in a Phase 1b clinical trial for the potential treatment of acute myeloid leukemia (AML).

Oncolytics Biotech® and SOLTI Present Positive Translational Data at SABCS

On December 7, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported the presentation of additional translational data from the AWARE-1 breast cancer window-of-opportunity study conducted in combination with SOLTI-Innovative Cancer Research at The San Antonio Breast Cancer Symposium (SABCS) (Press release, Oncolytics Biotech, DEC 7, 2023, View Source [SID1234638252]).

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"Translational data presented from the AWARE-1 study at SABCS showed that pelareorep induced the expansion of tumor-infiltrating lymphocytes, or TILs, in matched tumor biopsy and peripheral blood samples of newly diagnosed breast cancer patients. In addition, sequencing of the T cell receptors (TCRs) showed a more prominent expansion of existing TIL clones in the blood. We consider these results to be positive and important because they build on additional translational results reported this fall at two other medical meetings, The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), from the AWARE-1 and GOBLET studies respectively, and provide further support for pelareorep’s unique immunologic mechanism of action," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Taken together, these translational data affirm pelareorep’s ability to enhance T cell infiltration into tumors and expand TILs in the peripheral blood, which have been correlated with tumor response. We intend to incorporate these learnings into the designs of our registrational studies in metastatic breast cancer and pancreatic cancer."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, commented, "A review of the AWARE-1 study translational data presented at this year’s SABCS and previous scientific conferences demonstrates that pelareorep treatment, especially in combination with atezolizumab, results in:

•an increase in CelTIL score, which correlates with improved clinical outcomes in breast cancer
•increased CD8+ T cell infiltration into tumors
•the generation and expansion of T cell clones, especially TILs
•the upregulation of tumor PD-L1 expression

These findings confirm that pelareorep remodels the tumor microenvironment and stimulates tumor-directed immune responses, effects we believe are driven by the introduction of pelareorep’s double-stranded RNA into cancer cells."

Dr. Heineman concluded, "Results from multiple prior studies lead us to believe that pelareorep has the potential to fill very important treatment gaps for both breast and pancreatic cancer patients. The translational data reported this fall emphasize the importance of TIL clone expansion in pelareorep-treated patients and represents an important area for further exploration. We believe that analysis of TIL clone expansion could become a helpful precision tool to provide an early indication of treatment response and serve as a potential guide to patient care with pelareorep. We remain dedicated to expeditiously advancing the clinical development of pelareorep in support of our goal to provide cancer patients with improved treatment options."

Summary of Data and Findings for TIL-TCR-Seq from the AWARE-1 Study:

Samples: From the AWARE-1 window-of-opportunity study of patients with early-stage HR+/HER2- breast cancer:
•Collected from two patient cohorts, treated with pelareorep plus letrozole (cohort 1) or pelareorep plus letrozole and atezolizumab (cohort 2)
•Matched tumor and peripheral blood samples collected at two time points:
o#1 at the beginning of the study on Day 1 and

o#2: Day 21 – when tumors were surgically removed

Evaluation:
•Composite T cell scores, a tool to evaluate cellularity, previously analyzed according to the CelTIL scale; data provided in the poster for reference
•T cell fractions, to assess the TIL-fraction of T cells
•T cell Receptor Analysis, using T cell receptor sequencing (TCR Seq) as a proxy to analyze the number of TIL-specific clones and assess their origin, from pre-existing or new clones
•T cell data was analyzed to assess T cell clonal expansion according to origin (existing or new) at both time points (baseline and Day 21) and tissue samples (tumor biopsy or peripheral blood), using Adaptive Biotechnology’s Immunoseq’s protocol

Results: Pelareorep induced the expansion of existing TIL clones as well as new clones. These data are consistent with results from posters recently presented at SITC (Free SITC Whitepaper) and ESMO (Free ESMO Whitepaper) and affirm that pelareorep functions as an immunotherapeutic agent.
•CelTIL showed a composite increase in T cells: as previously reported, the majority of patients in both cohorts achieved an increase in CelTIL scores, with 60% of patients in Cohort 2 achieving a 30% increase in CelTIL scores, the primary endpoint of the study
•T cell fractions showed that TILs increased in both study cohorts (1.27 fold in Cohort 1, 2.74 fold in Cohort 2), with a greater increase in Cohort 2
•Clonal expansion results showed that pelareorep induced an expansion of TILs in tumor and peripheral blood with:
oIn tumors, new clones were more prominent
oIn peripheral blood, existing clones were more prominent
oIn cohort 2, there was greater overall expansion (qualified by the small numbers)

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. AWARE-1 met its primary endpoint of overall CelTIL score in 2021 (link to the PR, link to the poster). Additional biomarker data announced in 2022 showed pelareorep’s potential to improve the prognosis of breast cancer patients (link to the PR, link to the poster).

Poster Information
Poster Title T Cell Receptor Sequencing to Monitor Pelareorep-Induced Expansion of Tumor Infiltrating Lymphocytes
Presentation ID PO1-02-01
Session Poster Session 1
Poster Date & Time Wednesday, December 6, 2023 from 12 p.m. – 2 p.m. Central Time

A copy of the poster is available on the Oncolytics website and can be found by clicking here.