Adicet Bio to Participate in Upcoming Investor Conferences

On November 1, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that company management will participate in three upcoming investor conferences in November (Press release, Adicet Bio, NOV 1, 2024, View Source [SID1234647644]).

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!

Details of the events are as follows:

Truist Securities BioPharma Symposium, November 7, 2024, New York, NY

Members of management will be available for 1×1 meetings on November 7, 2024
Guggenheim Securities Healthcare Innovation Conference, November 11-13, 2024, Boston, MA

Chen Schor, President and Chief Executive Officer, will participate in a fireside chat on November 12, 2024 at 3:00 p.m. ET
Jefferies London Healthcare Conference, November 19-21, 2024, London

Chen Schor, President and Chief Executive Officer, will participate in a fireside chat on November 19, 2024 at 12:30 p.m. BST
The live audio webcasts of the fireside chats can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin® in Colorectal Cancer

On November 1, 2024 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported the publication of data from the Phase 1/2a study of Radspherin in colorectal cancer patients in the peer-reviewed Journal of Surgical Oncology (Press release, Oncoinvent, NOV 1, 2024, View Source [SID1234647643]). The results, previously presented at the 2023 Peritoneal Surface Oncology Group International (PSOGI) Congress in Venice, show encouraging 18 months safety and efficacy data from the 23 patients enrolled in the Phase 1 part of the RAD-18-002 study in colorectal cancer patients.

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!

"We are pleased to see our data published in such a well-recognized scientific journal," commented Professor Emeritus Oyvind Bruland, MD, PhD, senior author on the manuscript, co-founder and member of Oncoinvent’s scientific advisory board. "The data in the publication highlights the potential of Radspherin in treating patients with peritoneal metastases from colorectal cancer, a condition for which there is an urgent unmet need for novel treatment options."

"Patients with liver and lung metastases benefit considerably from several other new treatment options, but not those with peritoneal metastases," commented Stein G. Larsen, MD, PhD, principal investigator of the study and chief gastrosurgeon, the Norwegian Radium Hospital, Oslo University Hospital.

The publication concludes that Radspherin was well tolerated following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). At 18 months, none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. Radspherin also showed a promising signal of efficacy warranting further clinical evaluation. Results from 24 more patients treated with Radspherin in the RAD-18-002 study are pending.

The Journal of Surgical Oncology publication is available online at: View Source

About the RAD-18-002 Study

RAD-18-002 is a Phase 1/2a open-label study designed to select the clinical dose, and evaluate the safety, tolerability, and signal of efficacy of intraperitoneally administered Radspherin in patients with peritoneal metastases from colorectal cancer scheduled for cytoreduction and HIPEC. The study was closed for recruitment at the end of 2023.

About Radspherin

Radspherin is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of billions of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation.

Radspherin is investigated in ongoing clinical studies to treat peritoneal metastases from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.

HanAll Biopharma Reports Q3 2024 Financial Results and Provides Business Update

On November 1, 2024 HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the third quarter of 2024 and provided business updates (Press release, HanAll Biopharma, NOV 1, 2024, View Source [SID1234647642]).

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!

HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical sales reached 34 billion KRW from robust sales of key products.

In the third quarter, HanAll’s anti-FcRn assets demonstrated potential as best-in-class treatments for a range of autoimmune diseases, particularly Graves’ Disease. Ongoing studies include a Phase 2b trial in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) as well Phase 3 studies in generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED), with topline results expected in the first quarter of 2025 and first half of 2025, respectively.

Additionally, HanAll, in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed the Phase 1 study of HL192 in healthy subjects. Results for the HL192 Phase 1 study are anticipated in November of this year.

"This past quarter, HanAll’s focus and agile execution have positioned us for significant growth while allowing us to continue our R&D efforts through strategic, value enhancing cost optimization. Looking ahead, we are committed to expanding our competitive advantage by specializing in key products and strengthening our R&D capabilities as we strive to realize our highest potential as a global company," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.

Third Quarter 2024 BUSINESS UPDATE
Pipeline Development Highlights
A comprehensive update of HanAll’s public pipeline development below includes an overview of research along with lists of compounds, targeted indications and developmental phases.

AUTOIMMUNE DISEASES PROGRAMS
Batoclimab (HL161BKN)
A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases, batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies

Immunovant, a member of the Roivant group of companies, as well as HanAll’s licensed partner in the United States and Europe, is making progress across four autoimmune indications. Phase 3 studies in gMG and TED are advancing, with topline results expected in the first quarter of 2025 and first half of 2025, respectively.
Immunovant reported positive results from the Phase 2a study of batoclimab in Graves’ Disease. The study demonstrated that a higher dose of batoclimab achieved a 76% response rate in patients who were not adequately controlled on antithyroid drugs (ATDs) by 12 weeks of treatment. The ATD-free response rate for these patients at the same time point was 56%.
Immunovant is progressing with subject enrollment in the ongoing Phase 2b study for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The data obtained from this study will also be utilized to refine the study design for a potential registrational program for IMVT-1402 in CIDP. Initial results from the first period of the Phase 2b study are anticipated in the first quarter of 2025.
Harbour BioMed, another licensed partner which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in the Greater China region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), resubmitted the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in June 2024, which was accepted by the NMPA in July 2024. The BLA incorporated additional long-term safety data from the Phase 3 study in gMG which concluded in June 2023.
HL161ANS (IMVT-1402)
Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions, while minimizing interference with albumin recycling

Immunovant plans to initiate a pivotal study in Graves’ Disease (GD) leveraging findings from the batoclimab Phase 2a study in GD data. The results from the previous study indicate a significant correlation between the reduction of IgG levels and clinical outcomes, underscoring the potential of HL161ANS/IMVT-1402 as a best-in-class treatment option for patients with GD.
Immunovant intends to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the conclusion of the first quarter of 2025. Additionally, the company plans to commence studies for IMVT-1402 across a total of up to 10 indications (in the aggregate) by the end of the first quarter of 2026. The company is also exploring initiating a registrational development in gMG with IMVT-1402.
Immunovant will work to optimize the HL161ANS/IMVT-1402 CIDP trial design, drawing insights from the ongoing CIDP Phase 2b trial for batoclimab.
OPHTHALMIC DISEASE PROGRAM
Tanfanercept (HL036)
A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation

HanAll Biopharma and Daewoong Pharmaceutical are conducting the Phase 3 VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye disease. The topline results for the study are expected in 2026.
The Phase 3 VELOS-4 trial builds upon key insights gained from the completed Phase 3 VELOS-3 study. In VELOS-3, tanfanercept demonstrated a statistically significant improvement in the secondary efficacy endpoint of tear volume, as measured by unanesthetized Schirmer testing, in patients treated with tanfanercept compared to those in the vehicle group at week 8 (p=0.002). In addition, a post hoc analysis revealed that a notable proportion of participants in the tanfanercept group (14%) showed significant improvement (p=0.011) in the Schirmer test, with an increase of at least 10mm from baseline at week 8, compared to only 4% in the vehicle group.
The 2020 FDA Draft Guidance on Dry Eye Drug Development considers the proportion of participants achieving a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval.
NEUROLOGY PROGRAM
HL192 (ATH-399A)
A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School’s Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).

The Phase 1 study of HL192, being developed in collaboration with NurrOn Pharmaceuticals, HanAll Biopharma, and Daewoong Pharmaceutical, has completed dosing with the results expected in November 2024.
ONCOLOGY PROGRAMS
HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

HanAll decided to discontinue its monoclonal antibody programs targeting TIM-3 and TIGIT, following the recent data outcomes and decisions from other global companies to cease their programs. HanAll is exploring the potential for developing a new asset for a different oncology target.

Lilly to Present Results from Phase 3 EMBER-3 Study of Imlunestrant, an Oral SERD, and Additional Results from Its Breast Cancer Portfolio at the San Antonio Breast Cancer Symposium

On November 1, 2024 Eli Lilly and Company (NYSE: LLY) reported that data from the Phase 3 trial (EMBER-3) for imlunestrant, an oral selective estrogen receptor degrader (SERD), will be reported for the first time in a late-breaking oral presentation at the San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, TX (Press release, Eli Lilly, NOV 1, 2024, View Source [SID1234647641]). EMBER-3 is a study in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The trial is evaluating imlunestrant alone or in combination with Verzenio (abemaciclib; CDK4/6 inhibitor), in patients who were pretreated with endocrine therapy, with or without a CDK4/6 inhibitor.

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!

Lilly will also share results of a real-world analysis of risk of recurrence by nodal status and high-risk features in patients with hormone receptor positive (HR+), HER2- early breast cancer. Additional presentations from investigational mutant selective PI3Ka inhibitor assets include preclinical characterization data for LY4045004, which is expected to enter the clinic in the first half of 2025, and Phase 1a/b clinical data for a predecessor molecule, LOXO-783, which informed the development of LY4045004.

A full list of abstract titles and viewing details are listed below:

Imlunestrant (investigational oral SERD)
Presentation Title: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients with ER+, HER2- Advanced Breast Cancer (ABC), Pretreated with Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial.
Presentation Number: GS1-01
Presentation Date & Time: Wednesday, Dec.11, 2024, 9:15-9:30 a.m. CST
Location: Hall 1
Presenter: Komal Jhaveri

Presentation Title: Patient and health care provider perspectives on oral versus intramuscular endocrine therapy for locally advanced or metastatic breast cancer
Presentation Number: P4-03-11
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Rebecca Speck

Presentation Title: Evaluation of pharmacokinetics and safety of imlunestrant in participants with hepatic impairment
Presentation Number: P4-10-07
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Xuejing Aimee Wong

Real World Evidence
Presentation Title: Risk of Recurrence by Nodal Status and High-Risk Features in Patients with HR+, HER2-, Early Breast Cancer: An Analysis of Real-world Data
Presentation Number: P1-11-02
Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Sara Tolaney

Verzenio (abemaciclib)
Presentation Title: Genomic profiling of ctDNA and association with efficacy in patients from the postMONARCH trial of abemaciclib + fulvestrant vs placebo + fulvestrant for HR+, HER2-, advanced breast cancer following progression on a prior CDK4/6i plus endocrine therapy
Presentation Number: P1-01-26
Presentation Date &Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Seth Wander

Presentation Title: Clinical Characteristics and Treatment Persistence in US Patients with HR+/HER2-, Node Positive Early Breast Cancer Treated with Abemaciclib: Real-World Study from First Year After Approval
Presentation Number: P1-11-29
Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Hatem Soliman

Presentation Title: Unveiling the Antitumor Mechanism of abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin Analysis
Presentation Number: P5-02-23
Presentation Date & Time: Friday, Dec.13, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Mamoru Takada

PI3Ka Inhibitor (LOXO-783)
Presentation Title: A first-in-human phase 1a/b trial of LOXO-783, a potent, highly mutant-selective, brain-penetrant, allosteric PI3Kα H1047R inhibitor advanced breast cancer and other solid tumors: Results from the PIKASSO-01 study
Presentation Number: PS7-03
Presentation Date & Time: Wednesday, Dec.11, 2024, 7-8:30 a.m. CST
Location: TBD
Presenter: Komal Jhaveri

Next-Gen PI3Ka Inhibitor (LY4045004)
Presentation Title: Preclinical characterization of LY4045004, a next-generation, mutant-selective PI3Kα inhibitor
Presentation Number: P4-12-24
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Raymond Gilmour (Lilly)

About Verzenio (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients. The National Comprehensive Cancer Network (NCCN) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.1 NCCN also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.1

The collective results of Lilly’s clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, an adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a high-risk population.2 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.3 Verzenio has shown a consistent and generally manageable safety profile across clinical trials.

Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.

INDICATIONS FOR VERZENIO
VERZENIO is a kinase inhibitor indicated:

in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.

in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)
Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of diarrhea ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.

Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in EBC (monarchE), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in MBC (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.

Grade ≥3 increases in alanine aminotransferase (ALT) (2 to 6%) and aspartate aminotransferase (AST) (2 to 3%) were reported in patients receiving Verzenio. Across three clinical trials in 3559 patients (monarchE, MONARCH 2, MONARCH 3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days. The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days.

Monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase elevation.

Venous thromboembolic events (VTE) were reported in 2 to 5% of patients across three clinical trials in 3559 patients treated with Verzenio (monarchE, MONARCH 2, MONARCH 3). VTE included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. In clinical trials, deaths due to VTE have been reported in patients treated with Verzenio.

Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for EBC patients with any grade VTE and for MBC patients with a Grade 3 or 4 VTE.

Verzenio can cause fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥10%) observed in monarchE for Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of ≥2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7 %).

The most frequently reported ≥5% Grade 3 or 4 adverse reaction that occurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).

Lab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of ≥2% were increased serum creatinine (99% vs 91%; .5% vs <.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2 % vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for Verzenio plus anastrozole or letrozole with a difference between arms of ≥2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant with a difference between arms of ≥2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%).

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products.

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min).

Please see full Prescribing Information and Patient Information for Verzenio.

AL HCP ISI 12OCT2021

About Imlunestrant
Imlunestrant is an oral selective estrogen receptor (ER) degrader, that delivers continuous ER inhibition, including in ESR1-mutant cancers.

The estrogen receptor (ER) is the key therapeutic target for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. Imlunestrant is currently being studied as a treatment for advanced breast cancer and as an adjuvant treatment in early breast cancer, including: NCT04975308, NCT05514054, NCT04188548, NCT05307705.

Verzenio is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

The Phase III clinical trial application for first-line treatment of extensive disease small cell lung cancer with Chiauranib has been approved

On November 1, 2024 Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Ltd., reported to have received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration (Press release, Shenzhen Chipscreen Biosciences, NOV 1, 2024, View Source [SID1234647640]). The company’s self-developed original new drug, Chiauranib, combined with PD – (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials.

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!

Extensive disease small cell lung cancer (ES-SCLC), as a highly aggressive subtype of lung cancer, has long been a huge challenge in the field of treatment. In recent years, chemo-immunotherapy has greatly improved the survival outcomes of patients with small cell lung cancer. However, compared to other types of tumors, there is still great room for improvement in the long-term survival of patients with small cell lung cancer. Chiauranib has a multi pathway pharmacological mechanism and has unique anti-tumor activity against neuroendocrine tumors such as small cell lung cancer. At the same time, it can produce synergistic effects with immunotherapy and chemotherapy through its dual effects of anti-angiogenesis and immune regulatory activity. On the basis of first-line chemo-immunotherapy, the introduction of the new regimen of Chiauranib is expected to further improve the long-term survival of patients with extensive stage small cell lung cancer, demonstrating enormous clinical treatment potential.

In addition to the approved Phase III clinical trial, the phase III clinical trial of Chiauranib monotherapy for the later-line treatment of small cell lung cancer has been completed and the Pre NDA is currently under communication. The phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer, and the phase II clinical trial of single or combined treatment for triple negative breast cancer, soft tissue sarcoma and pancreatic cancer are also being progressed. In terms of overseas clinical trials, the phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer / solid tumor is in progress in the United States.

About Chiauranib

Chiauranib is a novel molecular entity independently designed and developed by the Chipscreen Biosciences, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug candidate.

Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. Chiauranib has outperformed drugs with a similar mechanism in overall efficacy and safety profile.