On June 2, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported the latest data from the inaugural global pivotal study WU-KONG1 Part B (WU-KONG1B) of sunvozertinib in relapsed or refractory non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Dizal Pharma, JUN 2, 2024, View Source [SID1234643947]). The study demonstrated statistically significant outcomes on the primary endpoint for sunvozertinib and highlighted its significant clinical value to patients around the globe.

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As a rationally designed, oral, potent EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity, sunvozertinib was previously granted Breakthrough Therapy designations by both the US FDA and the China Center for Drug Evaluation (CDE) in treating NSCLC with EGFR exon20ins. Sunvozertinib has obtained conditional approval in China through a phase II pivotal study (WU-KONG6), making it the world’s first and only oral drug for the treatment of NSCLC patients with EGFR exon20ins.

WU-KONG1B, a multinational pivotal study, is the equivalent study with a similar design of WU-KONG6 to investigate sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins from 10 countries and regions in Asia, Europe, North America, and South America. The primary endpoint and key secondary endpoint were independent review committee (IRC) assessed objective response rate (ORR) and duration of response (DoR) respectively.

As of March 22, 2024, a total of 111 patients were enrolled to receive sunvozertinib treatment at 300mg as the optimal recommended phase 2 dose (RP2D). 107 patients who met the full analysis set (FAS) definition were included in efficacy analysis, of which Asian, White, and Black or African American enrollees were 57.9%, 40.2% and 1.9%, respectively. The key findings of the primary analysis were as follows:

Per IRC assessment, sunvozertinib achieved a best ORR of 53.3%.
The median DoR has not been reached, and the 9-month DoR rate was 57%, indicating durable efficacy of sunvozertinib.
Anti-tumor efficacy was observed regardless of amivantamab treatment. The best ORRs in patients with or without prior amivantamab treatment were 50% and 53.8%, respectively.
Sunvozertinib was well tolerated with a favorable safety profile consistent with previous reports.
"The WU-KONG1B study is significant in that it enrolled more than 40% of non-Asian patients. On a global scale, sunvozertinib demonstrated potent and durable anti-tumor efficacy with a best ORR of 53.3% and a 9-month DoR of 57% in relapsed or refractory NSCLC patients with EGFR exon20ins. The revelation of 3 patients (2.8%) achieving a confirmed complete response (CR) indicated deep tumor shrinkage with sunvozertinib treatment." said Prof. James Chih-Hsin Yang, MD, PhD at National Taiwan University Hospital and National Taiwan University Cancer Center, the leading principal investigator of WU-KONG1B. "Safety findings were similar to what has been previously reported in other sunvozertinib clinical studies. The majority of treatment-related adverse events (TEAEs) were reversible and clinically manageable. We look forward to more data readouts to validate the clinical benefit of sunvozertinib in EGFR Exon20ins NSCLC."

"It’s encouraging to see that the global pivotal study demonstrated statistically significant and clinically meaningful benefits of sunvozertinib as a single agent in NSCLC patients with EGFR exon20ins. Compared to what is available, sunvozertinib offers significant advantages as a single, oral drug: convenient, safe, and superior efficacies." said Xiaolin Zhang, PhD, CEO of Dizal.

He added, "In parallel, we are advancing the development of sunvozertinib in the first-line setting of NSCLC with EGFR exon20ins through a global phase III study (WU-KONG28). The accumulated clinical data for sunvozertinib has attracted lots of attention and facilitated our studies. We want to thank our patients and investigators for their hard work. We are committed to accelerate ongoing clinical studies and make the drug available to patients globally as soon as possible."

WU-KONG28, a phase III, multinational, randomized study, is ongoing to assess sunvozertinib versus platinum-based doublet chemotherapy in the first-line setting with patients from 14 countries and regions in Asia, Europe, North America, and South America.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

On June 2, 2024 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that it will present a poster at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting entitled "Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors," that highlights clinical data for the potential best-in-class efficacy and safety of BAT8006 as a potential treatment for ovarian cancer patients and other patients with tumors that express Folate Receptor-alpha (Press release, BioThera Solutions, JUN 2, 2024, View Source [SID1234643946]). The poster will be available on the company website after the presentation per ASCO (Free ASCO Whitepaper) rules

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As of May 8, 2024, 156 subjects with advanced solid tumor were treated in phase 1 study. In 84 and 93mg/m2 dose optimal/expansion cohorts (including all advanced solid tumor subjects), 3.5% (2/57) and 3.9% (2/51) subjects experienced dose reduction, and 5.3% (3/57) and 13.7% (7/51) subjects experienced study drug interruption, respectively. No study treatment related death, and no ILD/pneumonitis and keratitis, uveitis, decreased vision was reported in this study. The major TRAEs were hematological toxicity. The dosages of 84 and 93 mg/m2 were selected in dose optimal study, the incidences of ≥ Grade 3 thrombocytopenia and neutropenia were 9% vs 28% and 19% vs 37%, respectively.

To the date of data cut-off, 54 subjects with platinum refractory or platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer were treated with BAT8006 doses of 1.8~2.4 mg/kg and 84/93mg/m2 and have received at least one tumor assessment. Among these patients, 38.9% (21/54) of them had undergone＞3 lines prior systemic treatment. Regardless of the FRα expression, the ORR including unconfirmed partial response (PR) is 37.0% (20/54). In subjects with FRα＜50%, FRα ≥50% and FRα ≥75%, the ORR is 33.3% (7/21), 39.4% (13/33) and 46.7% (7/15), respectively. With a median follow up of 6.5 months (1.3, 18.0 months), the median duration of response (mDOR) was 6.3 months (1.8-16.5months). The median progression free survival (mPFS) was 7.47 months (4.27~NA). The overall survival (OS) rate in 6 months and 1 year were 83.0%, 83.0%.

The safety of BAT8006 is favorable with manageable toxicity. No ILD and notable ocular toxicity was reported. The preliminary efficacy of BAT8006 was superior even in all platinum-resistant ovarian cancer patients regardless of the FRα expression. BAT8006 may benefit broad patient population while providing a promising efficacy. Exploration study on endometrial carcinoma, breast cancer and NSCLC is ongoing, the efficacy was demonstrated in these tumor type as well.

BAT8006 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8006 is currently being evaluated in a Phase 2 clinical study for the treatment of ovarian and other Folate Receptor-alpha overexpressed cancers. Clinical study of BAT8006 in combination with BAT1308, a PD-1 mAb, was recently approved by the NMPA.

Presentation details are as follows:

Poster Session:

Gynecologic Cancer

Session Date and Time:

Monday, June 3rd, 9:00 am – 11:00 am

Location:

Poster Area/Exhibition Hall

Abstract Number:

5550

Poster Board Number:

421

On June 2, 2024 Leading international medical research company, MEDSIR, reported the results of the recent PRIMED clinical trial during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, MedSIR, JUN 2, 2024, View Source [SID1234643945]). Carried out under the company’s collaborative model, this Investigator-Initiated Trial (IIT) demonstrated the effectiveness of preventative administration of drugs to treat the common side effects of neutropenia and diarrhea that can occur while taking sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 that has extended overall survival for patients with pretreated triple negative and HR-positive/HER2-negative advanced breast cancer in two previous Phase 3 studies, ASCENT and TROPiCS-02. In the PRIMED study, adding primary prophylactic granulocyte colony-stimulating growth factors (G-CSF) and loperamide during the first two sacituzumab govitecan treatment cycles led to clinically meaningful reductions in neutropenia and diarrhea, lowering the need for dose reductions, treatment interruptions, and permanent discontinuations.

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"This is an exciting finding that highlights the high potential of prophylactic strategies that can mitigate side effects to help keep patients on promising treatments, which was made possible by our collaborative research model," shared Dr. Antonio Llombart-Cussac, Senior Scientific Leader of MEDSIR. "By using a partnership model that combines the benefits of company-sponsored research with all the advantages of IITs, we are turning brilliant ideas into full clinical trials that will safely and efficiently advance cancer solutions. It is our hope that, by working together, we will continue to generate new opportunities for patients worldwide."

Among PRIMED study participants, the incidence of any grade of neutropenia (in the first two cycles) was 28%, compared to 63% and 70% in ASCENT and TROPiCS-02 (in the full study), respectively. The incidence of any grade diarrhea (in the first two cycles) was 34%, compared to 59% and 57% in ASCENT and TROPiCS-02 (in the full study), respectively. The other side effects PRIMED study participants experienced were consistent to the known safety profile of sacituzumab govitecan, with the exception of constipation, which occurred in 46% of patients during the first two cycles compared to 17% in ASCENT and 19% in TROPiC-02 (in the full study). However, most cases of constipation were mild, and no patients experienced adverse events that led to permanent treatment discontinuation.

The study, which is still ongoing to evaluate efficacy and collect longer-term safety data, enrolled 50 patients between February 2023 and September 2023 across 10 sites across Spain, providing them with G-CSF and loperamide during the first two sacituzumab govitecan treatment cycles (physician’s decision to continue after two cycles). These two drugs are commonly used to treat neutropenia and diarrhea, respectively, but are usually administered only after these side effects occur. In PRIMED, researchers wanted to test whether early administration of these drugs, before patients experienced any neutropenia or diarrhea, could reduce the incidence of these side effects and determine how this affected the need for dose reductions, treatment interruptions, and permanent discontinuations.

Showcasing Numerous Promising Collaborative Trials at ASCO (Free ASCO Whitepaper)

PRIMED was not the only trial MEDSIR presented during the ASCO (Free ASCO Whitepaper) Annual Meeting. It shared the results of several other recent and ongoing studies as well.

Recently published in The Lancet, MEDSIR’s PHERGain phase II trial (NCT03161353) demonstrated how a third of patients with HER2-positive early breast cancer could be safely treated without using chemotherapy. At the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, MEDSIR presented a subanalysis of this study comparing PET scan and magnetic resonance imaging (MRI) results; both tests that participants undergo to observe the evolution of their cancer. The comparative study shows tumor assessments can be analyzed with both PET scan and MRI. Although PET scan is the recommended imaging technique for early treatment response, this exploratory study suggests that MRI could alternatively guide the treatment when PET scan are not available.

MEDSIR’s PATHFINDER study evaluated the safety, tolerability, and preliminary efficacy of ipatasertib in combination with non-taxane chemotherapy in patients with advanced triple negative breast cancer who had previously experienced tumor progression after treatment with taxane chemotherapy. Study results revealed that combining ipatasertib with capecitabine and eribulin has an acceptable safety profile in these patients, but that adding ipatasertib alongside carboplatin plus gemcitabine proved to be intolerable. Additionally, the combination of ipatasertib and eribulin demonstrated encouraging efficacy, warranting further investigation.

TUXEDO-3, one of MEDSIR’s ongoing clinical trials in Austria and Spain, is the first study evaluating the efficacy and safety of patritumab deruxtecan as an anti-cancer therapy for patients with pretreated metastatic breast cancer and advanced non-small cell lung cancer with brain metastases, and metastatic solid tumors with leptomeningeal disease. If positive, this study could streamline the introduction of HER3-DXd as a new treatment for these patients who currently have very limited therapeutic options.

ABOUT UMMET CANCER NEEDS

Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care.

On June 2, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational radiodiagnostic PET[1] agent, TLX250-CDx (Zircaix[2], 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC) (Press release, Telix Pharmaceuticals, JUN 2, 2024, View Source [SID1234643944]).

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The rolling BLA submission, initiated in December 2023[3] with timelines pre-agreed with the FDA, was based on Telix’s successful global Phase III ZIRCON[4] study in ccRCC. The clear cell variant of renal cancer is the most common and aggressive sub-type of kidney cancer. The ZIRCON study met all co-primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in small, difficult to detect lesions[5].

As part of the BLA submission process, Telix has requested a Priority Review under the eligibility criteria of the Breakthrough Therapy designation[6]. If granted, this would potentially support an expedited review time. If Zircaix[2] is approved, TLX250-CDx will be the first targeted radiopharmaceutical imaging agent specifically for kidney cancer to be commercially available in the U.S. and further builds on Telix’s successful urology imaging franchise.

James Stonecypher, Chief Development Officer at Telix, stated, "Completing the BLA submission for TLX250-CDx represents a significant milestone for Telix as we bring our Breakthrough investigational kidney cancer imaging agent closer to market as a non-invasive diagnostic for patients. We believe TLX250-CDx is a natural follow-on product to Illuccix as it is targeted at the same clinical stakeholders, the urologist and urologic oncologist, and leverages the proven commercial and distribution infrastructure developed through the launch of Illuccix."

TLX250-CDx International Expanded Access

As part of Telix’s commitment to access to medicine, the Company has opened an expanded access program (EAP) in the U.S.[7], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options.

U.S. patients, or physicians who may have eligible patients in the U.S., can e-mail [email protected] or complete the form here for further information.

Physicians in Europe and Australia who may have eligible patients can email [email protected] and [email protected], respectively, for further information about TLX250-CDx named patient access.

Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

For more information about ongoing clinical trials of TLX250-CDx, please visit View Source

About TLX250-CDx (Zircaix[2])

TLX250-CDx (Zircaix[2]) is a PET diagnostic imaging agent that is under development to characterise indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, was completed in 2022 and met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers[5]. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation.

On June 2, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, next-generation ROS1 tyrosine kinase inhibitor (TKI), were published today in the Journal of Clinical Oncology (JCO) and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2024, View Source [SID1234643943]).

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Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib. Results showed taletrectinib shrank tumors (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 91% of patients who were ROS1 TKI-naïve and 52% of patients who had previously been treated with crizotinib (ROS1 TKI-pretreated). Taletrectinib continued to show robust activity in patients with disease that spread to the brain, as well as in patients with acquired resistance mutations, including G2032R.

After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively. Taletrectinib’s safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events (TEAEs).

Based on positive results from the pivotal Phase 2 TRUST-I study, two new drug applications (NDA) of taletrectinib have been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, and granted priority review designations, for first-line and second-line treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

"Current treatments for advanced ROS1-positive NSCLC have significant limitations, and people living with this disease remain in need of new options that are both well tolerated and offer durable responses," said Caicun Zhou, M.D., Ph.D., Principal Investigator of the TRUST-I study and Professor and Director of the Department of Oncology at Shanghai East Hospital, Tongji University. "These TRUST-I results reinforce taletrectinib’s strong efficacy and favorable safety profile, with longer follow-up, taletrectinib continues to show high and durable overall responses, robust intracranial and G2032R activity, with a low incidence of neurologic AEs. We look forward to taletrectinib benefits ROS1-positive NSCLC patients in the near future."

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, " The updated data of the TRUST-I study shows remarkably durable response and meaningful clinical benefits of taletrectinib for ROS1-positive NSCLC patients. We will continue close communications with our partner and regulatory authorities in China, hoping to bring this new generation of targeted therapy to patients with ROS1-positive NSCLC in China."

About ROS1-positive NSCLC

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 1-3% of people with NSCLC are ROS1-positive. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment. While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC who remain in need of new options.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors (TKIs).

In 2021, Innovent and AnHeart Therapeutics, a Nuvation Bio (NYSE: NUVB) Company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

About Phase 2 TRUST-I Study Results

TRUST-I (NCT04395677) is a pivotal Phase 2, multicenter, single-arm, open-label study evaluating taletrectinib as a monotherapy in 173 patients with advanced ROS1-positive NSCLC in China who either had not previously been treated with a ROS1 TKI (TKI-naïve) or had previously been treated with crizotinib (TKI-pretreated). Almost all patients received 600 mg of taletrectinib orally once-a-day in 21-day treatment cycles. 21% of TKI-naïve patients and 34% of TKI-pretreated patients had received prior chemotherapy, respectively. The primary endpoint of this registrational study was cORR as assessed by IRC, and key secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.

As of November 29, 2023, results from TRUST-I as assessed by an IRC showed:

In TKI-naïve patients (n=106):

90.6% of patients’ tumors shrank in response to taletrectinib treatment (cORR).
Taletrectinib shrank brain tumors in 87.5% of people who had measurable central nervous system tumors (n=8; intracranial cORR).
After median follow-up of 23.5 months, median duration of response and median progression-free survival were not reached.
At two years, 78.6% of patients who responded to taletrectinib treatment were still responding and 70.5% of patients were still progression-free.
In TKI-pretreated patients (n=66):

51.5% of patients’ tumors shrank in response to taletrectinib treatment (cORR).
Taletrectinib shrank brain tumors in 73.3% of people who had measurable central nervous system tumors (n=15; intracranial cORR).
Taletrectinib shrank tumors in 66.7% of patients with G2032R mutations (n=12).
After median follow-up of 9.7 months, median duration of response was 10.6 months and median progression-free survival was 7.6 months.
At nine months, 69.8% of patients who responded to taletrectinib treatment were still responding and 47.4% were still progression-free.
Taletrectinib’s safety profile was consistent with previous reports. The most frequent TEAEs were increased liver enzymes (increased aspartate aminotransferase: 76%; increased alanine aminotransferase: 68%); diarrhea (70%); vomiting (53%), and anemia (49%), most of which were grade 1 or 2. Incidence of neurologic TEAEs were low; the most common was dizziness (23%), most of which was grade 1. Discontinuations (5%) and dose reductions (19%) due to TEAEs were low.

The JCO publication, "Efficacy and Safety of Taletrectinib in Chinese Patients with ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study," is available at View Source

The corresponding oral presentation of the same name (Abstract #8520) will be delivered by Wei Li, M.D., a TRUST-I investigator and Professor at the Department of Medical Oncology at Shanghai East Hospital, Tongji University, at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting in the "Lung Cancer – Non-Small Cell Metastatic" session occurring today, Saturday, June 1, 2024, at 4:30-6:00 p.m. CT/5:30-7:00 p.m. ET.