On May 19, 2021 Sanofi reported that New research being presented at the upcoming virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8 highlights transformative science and commitment to patient care across difficult-to-treat cancers, including multiple myeloma, skin, lung and breast cancers (Press release, Sanofi, MAY 19, 2021, View Source [SID1234580286]).

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"Our pipeline of innovative investigational medicines continues to expand, supporting our goal to address critical gaps in treatment options for patients with cancers of high unmet need," says Peter C. Adamson, Global Development Head, Oncology at Sanofi. "We look forward to presenting the latest data across our oncology portfolio and pipeline in four key areas – multiple myeloma, skin cancers, lung cancers and breast cancer, including data supporting the potential for amcenestrant to become a best-in-class oral endocrine backbone therapy."

Early clinical data for amcenestrant, our investigational oral selective estrogen receptor degrader (SERD), show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer*

Abstract 1058: AMEERA 1: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with palbociclib (palbo) in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC)
Abstract TPS1104: AMEERA-5: A randomized, double-blind phase 3 study of amcenestrant (SAR439859) + palbociclib versus letrozole + palbociclib for previously untreated ER+/HER2- advanced breast cancer (Trial in Progress)
Click here to read the full amcenestrant data press release issued by Sanofi.

Data analyses reinforce Libtayo (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer indications and in advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastases

Libtayo in Non-melanoma Skin Cancer

Abstract 9547: Checkpoint inhibition in immunosuppressed or immunocompromised patients with advanced cutaneous squamous cell carcinoma (CSCC): Data from prospective CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.) study
Abstract 9566: Health-related quality of life (HRQoL) in patients (pts) with locally advanced basal cell carcinoma (laBCC) treated with cemiplimab: analysis of a phase II, open-label clinical trial
Abstract e18830: Budget impact (BI) analysis of cemiplimab-rwlc for advanced basal cell carcinoma (BCC) after hedgehog inhibitor (HHI) therapy in the United States

Other Sanofi studies in Non-Melanoma Skin Cancer

Abstract e18740: Frequency, characteristics, and subsequent treatment (Tx) of real-world patients (pts) who discontinue hedgehog inhibitors (HHI) as first-line (1L) systemic Tx for advanced basal cell carcinoma (aBCC)
Abstract e18742: Outcomes in patients (pts) with advanced basal cell carcinoma (aBCC) who discontinued hedgehog inhibitors (HHI) as first-line (1L) systemic treatment (Tx) in a US community oncology setting: A retrospective observational study
Libtayo in Non-small Cell Lung Cancer

Abstract 9085: Cemiplimab monotherapy as first-line (1L) treatment of patients with brain metastases from advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%; EMPOWER-Lung 1 subgroup analysis
Abstract 9078: Patient-reported symptoms, functioning, and quality of life (QoL) in patients treated with cemiplimab monotherapy for first-line treatment of advanced NSCLC with PD-L1 ≥50%: Results from EMPOWER-Lung 1 study
Abstract e18817: Budget impact (BI) analysis of cemiplimab for first-line (1L) advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% in the United States
Abstract e21091: Network meta-analysis (NMA) of immuno-oncology (IO) monotherapy (mono) as first-line (1L) treatments (txs) for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50%
Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Longer term data and new analyses for Sarclisa (isatuximab-irfc) further strengthen its efficacy profile, including for elderly patients and patients with high-risk cytogenetic abnormalities

Abstract 8017: Updates from ICARIA-MM, a Phase 3 study of isatuximab (Isa) plus pomalidomide and low-dose dexamethasone (Pd) versus Pd in relapsed and refractory multiple myeloma (RRMM)
Abstract 8042: Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics: IKEMA subgroup analysis
Abstract 8026: Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma: IKEMA subgroup analysis
Abstract e20015: Isatuximab plus carfilzomib and dexamethasone in East Asian patients with relapsed multiple myeloma: IKEMA subgroup analysis
Abstract 8034: Isatuximab plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma according to prior lines of treatment and refractory status: IKEMA subgroup analysis

Biomarker research for tusamitamab ravtansine, an early-stage, potential first-in-class investigational anti-CEACAM5 antibody drug conjugate for advanced non-small cell lung cancer*

Abstract e21030: Validation of an immunohistochemical assay, CEACAM5 IHC 769, under development for use with the antibody-drug conjugate tusamitamab ravtansine (SAR408701)

Safety, pharmacokinetic and pharmacodynamic data with our investigational transforming growth factor beta (TGF-b)*

Abstract 2510: Safety, pharmacokinetic and pharmacodynamic results from dose escalation of SAR439459, a TGFβ inhibitor, as monotherapy or in combination with cemiplimab in a phase 1/1b study

Early data with investigational anti-ICOS antibody, KY1044, submitted by Kymab, a Sanofi company*

Abstract 2624: A phase 1/2 open-label study of KY1044, an anti-ICOS antibody with dual mechanism of action, as single agent and in combination with atezolizumab, in adult patients with advanced malignancies
Abstract 2626: KY1044 to target the ICOS pathways inducing intratumoral Treg depletion and agonism of effector T cells: Preliminary pharmacodynamic markers from a phase 1/2 multicenter trial
Independent research supported by Sanofi

Jevtana (Cabazitaxel)
Abstract 5059 First results from a randomized Phase II study of cabazitaxel (CBZ) versus an androgen receptor targeted agent (ARTA) in patients with poor-prognosis castration-resistant prostate cancer (mCRPC)
Abstract 1008 Randomised multicentre trial of 3 weekly Cabazitaxel versus weekly Paclitaxel chemotherapy in the first line treatment of HER2 negative metastatic breast cancer (MBC)
Abstract e17027 Prostate cancer intensive, non-cross reactive therapy (PRINT) for CRPC: interim analysis of efficacy endpoints
Click here to view these abstracts along with the full digital program located in the ASCO (Free ASCO Whitepaper) Meeting Library.

*These assets are currently under investigation and their safety and efficacy has not been fully evaluated by any health authority.

On May 19, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported updated interim clinical data from the oral presentation on its ongoing Phase 1/2 clinical trial evaluating TK216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma, to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting (Press release, Oncternal Therapeutics, MAY 19, 2021, View Source [SID1234580285]).

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Ravin Ratan, M.D., Assistant Professor, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, will present at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting Sarcoma oral session that two heavily pre-treated and metastatic Ewing sarcoma patients treated at the recommended Phase 2 dose (RP2D) of TK216 continue to demonstrate prolonged complete regression of Ewing sarcoma for greater than one and two-years on study and have tolerated ongoing treatments well with TK216 alone or in combination with vincristine.

The data will be presented at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting:

Abstract Title: TK216 for Relapsed/Refractory Ewing Sarcoma: Interim Phase 1/2 Results
Abstract number: 11500
Session Title: Sarcoma
Session Date and Time: June 4, 2021, from 1:30 – 4:30 p.m. (Eastern Time)
"I am optimistic about the durable disease control observed in the two heavily pre-treated metastatic patients with Ewing sarcoma, and that both tolerated their treatments with TK216 with or without vincristine well," said Dr. Joseph Ludwig, M.D. Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center. "Advanced, refractory Ewing sarcoma is a serious and devastating condition, and novel therapies are desperately needed. These encouraging interim results from study TK216-01, along with evolving preclinical data, suggest that this agent may warrant further clinical development."

As of the April 16, 2021 data cut-off date, a total of 68 patients with relapsed/refractory Ewing sarcoma have been treated with TK216 in study TK216-01, 29 patients in the dose-finding cohorts, and 39 patients treated at the RP2D of TK216 (200 mg/m2/day for 14 days) with vincristine 0.75-1.5 mg/m2 administered on the first day of each cycle. All patients treated at the RP2D had metastases at study entry and were heavily pretreated, with a median number of three prior systemic therapies (range 1-8). Two patients treated at the RP2D have achieved marked and sustained regression in target lesions after as little as two cycles of therapy. The first patient experienced 100% regression of target lesions following two cycles of TK216 alone. After six cycles of treatment that included concomitant vincristine starting in the third cycle, a single 7 mm non-target lung lesion was resected, resulting in a surgical complete remission. The patient remained on study with no evidence of disease after more than 24 months. The second patient attained 90% resolution of target lung lesions following two cycles of TK216 plus vincristine, then achieved a CR after six cycles of therapy. This patient also remained on study disease-free after more than 14 months, treated with TK216 alone following cycle 5. At the RP2D, the objective response rate (ORR) was 9.7% (3 of 31 evaluable patients), including one patient with an unconfirmed partial response (PR). Eleven patients (35.5%) had stable disease (SD), for a disease control rate (CR, PR, SD) of 45.2% (14 of 31 evaluable patients). The median progression-free survival (PFS) for patients treated at the RP2D was 1.9 months (95% CI: 1.5, 3.0), with an encouraging tail of extended PFS for some patients. Updated safety data showed that TK216 at the RP2D has been generally well tolerated, with frequent side effects including myelosuppression, fatigue, and alopecia. No unexpected off-target toxicities or deaths related to TK216 toxicity have been observed.

"We are encouraged by the durable clinical responses in this updated clinical data set, and the sustained disease control observed in two heavily pre-treated patients with refractory metastatic Ewing sarcoma treated with TK216 with or without vincristine," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "This first-in-class investigational agent may also have potential in a variety of other malignancies driven by ETS alterations including acute myeloid leukemia, large B-cell lymphoma and prostate cancer."

About TK216
TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins including fusion proteins. Tumorigenic fusion proteins involving the EWS protein and an ETS protein can be found in most cases of Ewing sarcoma. ETS-related translocations or overexpression are also found in many other tumors such as prostate cancer, acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). TK216 was developed based on discoveries in the laboratory of Jeffrey Toretsky, M.D., at Georgetown Lombardi Comprehensive Cancer Center, who discovered inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 was observed to bind to EWS-FLI1, blocking the interaction between this fusion protein and other transcriptome proteins such as RNA helicase A, leading to tumor cell apoptosis and inhibiting tumor growth in animal models. The U.S. Food and Drug Administration (FDA) has granted Orphan Designation, Fast Track designation, and Pediatric Rare Disease Designation to TK216 for the treatment of Ewing sarcoma. TK216 is an investigational medication that has not been approved by the FDA for any indication.

About Study TK216-01
TK216 is being evaluated in an ongoing Phase 1/2 clinical study as a single agent and in combination with vincristine in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer with no standard treatment available after first-line chemotherapy. The dose-finding portion of the study is complete. Oncternal is currently enrolling patients in a Phase 2 expansion cohort to evaluate the clinical response of treatment with TK216 in combination with vincristine using the recommended Phase 2 dosing regimen. This multi-center study is enrolling patients at nine clinical trial centers across the U.S. Additional information about the TK216 study may be accessed at ClinicalTrials.gov (NCT02657005).

On May 19, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported new data on its cancer tests and treatment guidance tools will be showcased in seven presentations and one e-abstract at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually June 4-8 (Press release, Exact Sciences, MAY 19, 2021, View Source [SID1234580284]). Data presented will reinforce the value of the Oncotype DX tests in informing personalized treatment decisions and highlight industry research from Thrive, an Exact Sciences company, outlining the need to incorporate a blood-based, multi-cancer screening test into routine clinical care.

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Exact Sciences Strengthens Evidence Supporting Cologuard and Oncotype DX Tests w Multiple Data Presentations @ASCO ’21
"We’re thrilled to participate in ASCO (Free ASCO Whitepaper), alongside our collaborators at leading academic and medical institutions," said Kevin Conroy, chairman and CEO of Exact Sciences. "Exact Sciences is changing the way we detect and treat cancer. The data being presented demonstrate our commitment to providing earlier answers and life-changing treatment guidance to patients and physicians, while strengthening our current tests and accelerating the introduction of new, innovative diagnostics."

Studies supporting Exact Sciences screening and earlier detection efforts consist of a Cologuard (mt-sDNA) modeling study in collaboration with Mayo Clinic to assess the impact of sessile serrated polyps on predicted colorectal cancer outcomes with Cologuard or FIT screening1, and clinical research from Thrive that emphasizes the need for integrating a multi-cancer screening test into the standard of care2.

Data being presented on the Oncotype DX test portfolio include a new analysis, based on first results from the independent RxPONDER study, that reinforce the cost-effectiveness of the Oncotype DX Breast Recurrence Score test in node-positive early-stage breast cancer3; an oral presentation from the West German Study Group (WSG) on the prospective phase III ADAPT study which used the Oncotype DX test to stratify patients with early-stage breast cancer4; and results from a patient-specific meta-analysis of three validation studies of the Oncotype DX Colon Recurrence Score test5.

Also being presented are findings from City of Hope’s Center for Precision Medicine that emphasize a comprehensive sequencing approach to help guide cancer treatment and assess risk for cancer and non-cancer diseases, using Exact Sciences’ GEM ExTra panel6, and early study results from PFS Genomics Inc., a development stage company founded by radiation oncologists, recently acquired by Exact Sciences. PFS Genomics has identified a gene expression signature, named Profile for the Omission of Local Adjuvant. Radiation (POLAR), to predict whether women with early-stage invasive breast cancer, treated with breast conserving surgery, are likely to benefit from radiotherapy7.

Following are the seven abstracts that have been accepted at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The on-demand materials, including posters, will be available in the ASCO (Free ASCO Whitepaper) Meeting Library, starting at 9:00AM EDT on June 4, 2021.

Impact of the Sessile Serrated Polyp Pathway on Predicted Colorectal Cancer Outcomes in the CRC-AIM Model
Authors: Kisiel, J., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10545

Cancer screening utilization in patients diagnosed with cancer types with and without recommended screening modalities
Authors: Cohain, A., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10557

Utilizing commercial health insurance claims data to identify the impact of cancer screening and estimate the added benefit of a multi-cancer liquid biopsy ordered during routine physical exams
Authors: Cohain, A., Hathaway, C., et al.
Session: Publication Only: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: e22516

Cost-effectiveness of Oncotype DX Breast Recurrence Score test in postmenopausal women with node-positive early breast cancer based on the RxPONDER trial
Authors: Berdunov, V., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 534

Prognostic impact of Recurrence Score, endocrine response and clinical-pathological factors in high-risk luminal breast cancer: Results from the WSG-ADAPT HR+/HER2- chemotherapy trial
Authors: Gluz, O., et. al
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 504; Oral presentation on June 6, 2021 at 8 AM EDT.

Discovery and validation of a genomic signature to identify women with early-stage invasive breast cancer who may safely omit adjuvant radiotherapy after breast-conserving surgery
Authors: Sjöström, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 512

Patient-specific meta-analysis of 3 validation studies of the 12-gene Colon Cancer Recurrence Score Assay for recurrence risk assessment after surgery with or without 5FU and oxaliplatin.
Authors: Yothers, G., et al.
Session: Gastrointestinal Cancer – Colorectal and Anal
Abstract Number: 3599

Prospective genomic testing of unselected cancer patients yields insights about cancer susceptibility and non-cancer disease with therapeutic implications
Authors: Gray, S., et al
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10603

On May 19, 2021 Incyte (Nasdaq: INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held virtually from June 4-8, 2021 (Press release, Incyte, MAY 19, 2021, View Source [SID1234580283]).

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"We look forward to presenting data from across Incyte’s oncology portfolio and partner programs at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Data being presented during this congress, including new three-year data from the L-MIND study of tafasitamab in relapsed or refractory diffuse large B-cell lymphoma as well as results of the OPTIC study of ponatinib in chronic phase-chronic myeloid leukemia, underscore our continued focus on advancing science to help meet patients’ needs."

Key abstracts accepted by ASCO (Free ASCO Whitepaper) include:

Oral Presentations

Ponatinib

OPTIC Primary Analysis: A Dose-Optimization Study of 3 Starting Doses of Ponatinib (PON)1(Abstract #7000. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.)

Poster Discussions

Tafasitamab

Long-Term Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)2 (Abstract #7513. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.)

Capmatinib

Capmatinib in MET Exon 14-Mutated, Advanced NSCLC: Updated Results from the GEOMETRY Mono-1 Study3(Abstract #9020. Session: Lung Cancer—Non-Small Cell Metastatic.)

ePosters

Capmatinib

Capmatinib Efficacy in Patients with NSCLC Identified as METex14 Using an NGS-Based Liquid Biopsy Assay: Results from the GEOMETRY Mono-1 Study3(Abstract #9111. Session: Lung Cancer—Non-Small Cell Metastatic.)

Patient-Reported Outcomes in Capmatinib-Treated Patients with METex14-Mutated Advanced NSCLC: Results from the Phase 2 GEOMETRY Mono-1 Study3(Abstract #9056. Session: Lung Cancer—Non-Small Cell Metastatic.)

Phase 1b/2 Study of Capmatinib Plus Gefitinib in Patients with EGFR-Mutated, MET-Dysregulated Non–Small Cell Lung Cancer who Received Prior Therapy: Final Overall Survival and Safety3(Abstract #9048. Session: Lung Cancer—Non-Small Cell Metastatic.)

Pemigatinib

Pemigatinib for Previously Treated Locally Advanced/Metastatic Cholangiocarcinoma (CCA): Update of FIGHT-202 (Abstract #4086. Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary.)

Retifanlimab

Phase 2 Study of Retifanlimab (INCMGA00012) in Patients (Pts) with Selected Solid Tumors (POD1UM-203) (Abstract #2571. Session: Developmental Therapeutics—Immunotherapy.)

Ruxolitinib-Parsaclisib Combination Studies

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ruxolitinib Plus Parsaclisib in Patients with JAK- and PI3K-Inhibitor Treatment–Naïve Myelofibrosis (Abstract #TPS7058. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.)

Tafasitamab

A Phase 3 Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo Plus Lenalidomide and Rituximab in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) (Abstract #TPS7568. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.)

First-MIND: A Phase 1b, Open-Label, Randomized Study to Assess Safety of Tafasitamab (tafa) or Tafa + Lenalidomide (LEN) in Addition to R‑CHOP in Patients with Newly Diagnosed DLBCL2(Abstract #7540. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.)

For full session details and data presentation listings, please see the ASCO (Free ASCO Whitepaper)21 online program at View Source Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at ASCO (Free ASCO Whitepaper) will be available on demand beginning Friday, June 4, 2021 at 9:00 a.m. ET.

On May 19, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported that Alpine will hold an investor event on June 4th, 2021 at 7:00pm ET, to coincide with the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting (Press release, Alpine Immune Sciences, MAY 19, 2021, View Source [SID1234580282]).

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During the investor event, Alpine will present data from the previously announced presentation on NEON-1, the company’s Phase 1 dose escalation clinical trial of ALPN-202 monotherapy, from the ASCO (Free ASCO Whitepaper) Virtual Annual Meeting ("First-in-human dose escalation of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies"). Following the presentation, Alpine will hold a question and answer discussion.

Currently, full abstracts are now live on the ASCO (Free ASCO Whitepaper) meeting website and a copy of Alpine’s presentation will be available on June 4th on the Scientific Publications page of Alpine’s website.

Investor Event – Conference Call and Webcast Details:

To access the investor event by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) and reference conference ID: 3439769.

A live webcast of the investor event will be available online in the investor relations section of the company’s website at View Source A replay will be available on the company website for 90 days following the webcast.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling. Alpine also plans the initiation of NEON-2, a combination study of ALPN-202 and a PD-1 inhibitor, later this year.