On November 30, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported it will present new data at San Antonio Breast Cancer Symposium (SABCS) 2023, supporting the use of Trodelvy (sacituzumab govitecan-hziy) in certain metastatic triple-negative breast cancer (mTNBC) and pre-treated HR+/HER2- metastatic breast cancer (mBC) patients.

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Data featured in eight presentations include an analysis of clinical outcomes by age from the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2- mBC, as well as a qualitative analysis of the experiences and perspectives of patients, caregivers and clinicians on clinical meaningfulness in mBC treatment decision-making. The study adds to a needed body of research exploring the importance of patient-centered interpretations of clinical meaningfulness (e.g., survival, quality of life).

"Trodelvy is the first approved Trop-2-directed ADC to significantly improve survival in both second-line metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer," said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. "The data being presented at SABCS add to the breadth of evidence reinforcing Trodelvy’s use in these two difficult-to-treat breast cancers. Additionally, the real-world data being presented in metastatic breast cancer provide insights on quality of life and other measures of health to inform both providers and patients in making treatment decisions."

Table of Accepted Abstracts (all times CDT):

Abstract Disposition

Abstract Title

Poster # PO1-05-09

Wednesday, Dec. 6

12:00 PM

ASCENT-07: A Phase 3, Randomized, Open-Label Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients with HR+/HER2- Inoperable, Locally Advanced, or Metastatic Breast Cancer Post-Endocrine Therapy

Poster # PO1-06-10

Wednesday, Dec. 6

12:00 PM

Overall Survival Results From EVER-132-001, a Phase 2B Single-Arm Study of Sacituzumab Govitecan in Chinese Patients with Metastatic Triple-Negative Breast Cancer

Poster # PO1-04-06

Wednesday, Dec. 6

12:00 PM

Exposure-response Analyses of Sacituzumab Govitecan Efficacy and Safety in Patients with Metastatic Breast Cancer

Poster # PO1-06-08

Wednesday, Dec. 6

12:00 PM

Treatment Utilization by Race and Insurance Type Among TNBC Patients

Poster # PO1-10-06

Wednesday, Dec. 6

12:00 PM

Understanding Clinical Meaningfulness in Metastatic Breast Cancer Treatment Decision-Making: Experiences and Perspectives of Patients, Caregivers, and Clinicians

Poster # PO2-05-03

Wednesday, Dec. 6

5:00 PM

Costs Associated with Adverse Events in Patients Receiving Treatment for Hormone Receptor Positive/Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer

Poster # PO2-05-02

Wednesday, Dec. 6

5:00 PM

Real-World Experience of Patients Receiving Treatment for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer: A Global Analysis of Symptoms and Side Effects

Poster # PO5-21-09

Friday, Dec. 8

12:00 PM

Clinical Outcomes by Age Subgroups in the Phase 3 TROPiCS-02 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in HR+/HER2‒ Metastatic Breast Cancer

Trodelvy is recommended as a category 1 preferred treatment for second-line mTNBC and a category 1 preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines).1

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved in almost 50 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy is also approved in the U.S., the European Union, and multiple other global markets to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer. In the U.S., Trodelvy also has accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer (UC); see below for the full U.S. indication for Trodelvy.

Trodelvy is also being developed for potential investigational use in other TNBC, HR+/HER2- and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

U.S. Indications for Trodelvy

In the United States, Trodelvy is indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
U.S. Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

Severe or life-threatening neutropenia may occur. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold Trodelvy until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to Trodelvy.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 64% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever. Administer G-CSF as clinically indicated or indicated in Table 1 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 64% of all patients treated with Trodelvy and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

In the TROPHY study (locally advanced or metastatic urothelial cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, any infection, alopecia, decreased appetite, constipation, vomiting, rash, and abdominal pain. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.

On November 30, 2023 Median Technologies reported that the Company will be presenting two scientific posters at the 2023 North America Conference on Lung Cancer (NACLC) being held in Chicago (Chicago Marriott Downtown Magnificent Mile), Il, USA, Dec. 1 – 3 (Press release, MEDIAN Technologies, NOV 30, 2023, View Source [SID1234638081]). The NACLC is organized by the International Association for the Study of Lung Cancer (IASLC), a global multidisciplinary association dedicated to eradication of all forms of lung cancers.

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The Company will give two poster presentations on December 2nd from 5:40 to 6:55 pm CT.

Poster PP01.49: End to End AI model for Nodule Detection and Characterization in Lung Cancer Screening: Performances and Subpopulation Analysis

Poster PP01.44: A CT Imaging Biomarker for CD8+ Lymphocytes Infiltration Stratification in Patients with Non-Small Cell Lung Cancer

Median’s eyonis and Imaging Lab teams will attend the event and be available for presenting the latest advances of eyonis AI/ML tech based SaMD and the Imaging Lab developments.

On November 30, 2023 Peptone, a leader in translational biophysics and the design of novel therapeutics against intrinsically disordered proteins (IDPs), and The Institute of Oncology Research (IOR) reported the commencement of a collaborative sponsored research agreement in prostate cancer (Press release, The lOR Institute of Oncology Research, NOV 30, 2023, View Source [SID1234638079]). The collaboration will focus on the identification and progression of novel targets in oncology using translational models to develop innovative medicines for patients suffering from prostate cancer.

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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

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"A collaboration with IOR combines Peptone’s unique expertise targeting disordered proteins with the power of generative machine learning, unique structural insights into disordered targets and patient insights about cancer born out of seminal work from Professor Alimonti’s group in Bellinzona," said Kamil Tamiola, PhD, CEO of Peptone. "Our collaboration is an excellent example of efficient technology transfer process and a burgeoning research and biotech ecosystem in Ticino, Switzerland."

Peptone is applying advanced biophysics atomic-level experimental approaches, including a novel ultra-low latency hydrogen-deuterium exchange mass spectrometry (HDX-MS), supercomputing and generative AI to interrogate and drug intrinsically disordered proteins (IDPs). IDPs are proteins that play a significant role in health and disease but because they lack a fixed structure, have been intractable or undruggable with conventional drug discovery approaches.

"Prostate cancer remains a highly prevalent disease with significant unmet clinical needs," said Professor Andrea Alimonti, MD, Incoming Director, and Professor of Molecular Oncology at IOR. "We are delighted to partner with Peptone on this research collaboration focused on novel target discovery in prostate cancer. Recent findings from my team demonstrate that advanced prostate cancer is regulated by several intrinsically disordered proteins, many of which can also control the tumor immune response. Targeting these proteins is a promising approach to this challenging disease."

On November 30, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy ("RT") (the "Company" or "Shuttle Pharmaceuticals"), reported that its Chief Executive Officer, Dr. Anatoly Dritschilo, will be participating in the Emerging Growth Conference on December 7, 2023 (the "Conference") (Press release, Shuttle Pharmaceuticals, NOV 30, 2023, View Source [SID1234638078]).

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Dr. Dritschilo will conduct a presentation and subsequently open the floor to questions during the Conference. If you have any questions, please submit your questions in advance to [email protected].

Dr. Dritschilo’s presentation will be on Thursday, December 7th 2023 at 10:15 am ET. A webcast link of the presentation can be found on the investor relations page of the Company’s website or accessed HERE.

If attendees are not able to join the event live on the day of the Conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, View Source

Dr. Dritschilo will also host one-on-one investor meetings after the Conference. To request a virtual one-on-one meeting with Dr. Dritschilo and the Company’s management team, please contact your respective Emerging Growth Conference representative or email the Company’s investor relations team at [email protected].

On November 30, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company and its partners will present two abstracts at the 2023 San Antonio Breast Cancer Symposium (SABCS) from December 5-9; 11 abstracts at the 65th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 9-12; and two abstracts at the International Association for the Study of Lung Cancer (IASLC) 2023 North America Conference on Lung Cancer (NACLC) from December 1-3 (Press release, Jazz Pharmaceuticals, NOV 30, 2023, View Source [SID1234638077]). New data include updated findings from a Phase 2a trial of the investigational HER2-targeted bispecific antibody zanidatamab in combination with palbociclib and fulvestrant as a chemotherapy-free option for HER2+/ HR+ metastatic breast cancer (mBC).

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"Following recent trial results showing the potential of zanidatamab to treat HER2-expressing gastric and biliary tract cancers at ASCO (Free ASCO Whitepaper) GI, ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) this year, we’re excited to share updated data at SABCS in HER2-amplified and hormone receptor-positive metastatic breast cancer when zanidatamab is used in combination to target the HER2, CDK4/6 and hormone receptor pathways," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "SABCS will also feature data from a trial of zanidatamab in neoadjuvant breast cancer. Additionally, we look forward to sharing new data through numerous presentations at ASH (Free ASH Whitepaper) 2023 that underscore our commitment to improving standards of care in blood cancer and other hematologic diseases, as well as real-world findings at NACLC that provide evidence of Zepzelca’s safety in clinical practice for the treatment of second-line small cell lung cancer."

Notable presentations at this year’s SABCS, ASH (Free ASH Whitepaper) and NACLC meetings include:

A SABCS oral presentation (late-breaking abstract) featuring primary results from a Phase 2a study for a chemotherapy-free option in heavily pretreated patients with HER2+/HR+ mBC treated with the combination of zanidatamab plus palbociclib and fulvestrant.
An investigator-sponsored (MD Anderson Cancer Center) SABCS poster presentation featuring results of a Phase 1 trial evaluating neoadjuvant zanidatamab in patients with stage 1 node-negative HER2+ breast cancer as a single-agent chemotherapy-free option.
An ASH (Free ASH Whitepaper) poster presentation of the complete pivotal, Phase 2/3 trial results of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) in acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL), which includes efficacy, safety and population pharmacokinetic modeling from intramuscular (IM) and intravenous (IV) dosing. The combination of observed and modeled results demonstrates Rylaze achieved therapeutic nadir serum asparaginase activity (NSAA) levels in the vast majority of patients via multiple dosing schedules with a safety profile consistent with prior studies and no new safety signals identified. Treatment‐related adverse events (TRAEs) ≥ grade 3 occurred in 126/228 (55%) patients with no TRAEs that led to death.1
Two NACLC poster presentations of real-world data for Zepzelca (lurbinectedin) in the second-line and later settings for the treatment of small cell lung cancer (SCLC).
The Jazz and partner-supported presentations at SABCS 2023 are:

Zanidatamab Presentations

Presentation Title

Author

Presentation Details (All times CDT)

Primary Results From a Phase 2a Study of Zanidatamab (zani) + Palbociclib (palbo) + Fulvestrant (fulv) in HER2+/HR+ Metastatic Breast Cancer (mBC)

Santiago Escrivá-de-Romani, et al.

Type: Oral

Session: Late Breaking Abstracts

Presentation Number: LBO1-04

Date/Time: Friday, December 8, 2023, 12:20 PM – 12:25 PM

Neoadjuvant Zanidatamab for Stage 1 Node Negative HER2 Positive Breast Cancer (BC)

[IST]

V. Valero, et al.

Type: Poster

Session: Spotlight poster session

Presentation Number: PS09-03

Date / Time: Wednesday, December 6, 2023, 5:30 PM – 6:30 PM

The Jazz-supported presentations at the 2023 ASH (Free ASH Whitepaper) Annual Meeting are:

Rylaze Presentations

Presentation Title

Author

Presentation Details (All times PDT)

Efficacy and Safety of Recombinant Erwinia Asparaginase in Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL): Complete Follow-up of the Children’s Oncology Group (COG) AALL1931 study

Luke Maese, et al.

Type: Poster

Number: 1498

Session: 614. Acute Lymphoblastic Leukemias: Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I

Date/Time: Saturday, December 9, 5:30-7:30 PM

Abstract Link

A Meta-analysis Comparing the Relative Efficacy of Pediatric-Inspired Regimens Versus Hyper-CVAD for the Treatment of Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Adolescents, Young Adults and Adults

Wenqing Su, et al.

Type: Poster

Number: 3779

Session: 905. Outcomes Research—Lymphoid Malignancies: Poster II

Date/Time: Sunday, December 10, 6:00-8:00 PM

Abstract Link

Asparaginase Collaboration Studies

Presentation Title

Author

Presentation Details

Overcoming Venetoclax (Ven) Resistance Through Glutamine (Gln) Depletion: Final Analysis of the Phase 1 Trial of Ven and Pegcrisantaspase (PegC) Combination in Relapsed and Refractory (R/R) Acute Myeloid Leukemia (AML)

Yuchen Liu, et al.

Type: Oral

Number: 60

Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Upcoming Therapies in Newly Diagnosed and Relapsed/Refractory AML

Date/Time: Saturday, December 9, 10:45 AM

Abstract link

Vyxeos Presentations

Presentation Title

Author

Presentation Details

Population Pharmacokinetic-Pharmacodynamic Modeling of Neutrophil and Platelet Count for Lower-Intensity Therapy of CPX-351 Combined With Venetoclax in Acute Myeloid Leukemia

Yali Liang, et al.

Type: Poster

Number: 2902

Session: 615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II

Date/Time: Sunday, December 10, 6:00-8:00 PM

Abstract Link

CPX-351 With Venetoclax in Patients with Relapsed/Refractory Acute Myeloid Leukemia: Results of a Phase Ib Study

Alex Bataller, et al.

Type: Poster

Number: 4259

Session: 615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III

Date/Time: Monday, December 11, 6:00-8:00 PM

Abstract link

Phase 2 Study of CPX-351 in Combination with Venetoclax in Patients with Newly Diagnosed, High Risk Acute Myeloid Leukemia

Wei-Ying Jen, et al.

Type: Poster

Number: 4273

Session: 615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III

Date/Time: Monday, December 11, 6:00-8:00 PM

Abstract link

Results of a Phase 1/2 Study of Lower Dose CPX-351 for Patients with Int-2 or High Risk IPSS Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia after Failure to Hypomethylating Agents

Guillermo Montalban-Bravo, et al.

Type: Poster

Number: 1873

Session: 637. Myelodysplastic Syndromes Clinical and Epidemiological: Poster I

Date/Time: Saturday, Dec. 9, 5:30 PM-7:30 PM

Abstract link

CRISPR/Cas9 Screen Identifies CPX-351 and 7+3 Regimens Response Modulators with Distinct Sensitive and Resistant Profiles

[IST]

Nam Nguyen, et al.

Type: Poster

Number: 1412

Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I

Date/Time: Saturday, Dec. 9, 5:30-7:30 PM

Abstract link

CPX-351 in Patients with Newly Diagnosed Post Myeloproliferative Neoplasms Acute Myeloid Leukemia

[IST]

Sylvain Garciaz, et al.

Type: Poster

Number: 2917

Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II

Date/Time: Sunday, Dec. 10, 6:00-8:00 PM

Abstract link

Defitelio Presentations

Presentation Title

Author

Presentation Details

Resolution of Veno-occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) With Defibrotide Following HCT in Adult and Pediatric Patients: Pooled Analysis of DEFIFrance and EBMT PASS Registries

Mohamad Mohty, et al.

Type: Poster

Number: 3527

Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster II

Date/Time: Sunday, December 10, 6:00-8:00 PM

Abstract link

A Phase II Study to Evaluate the Safety and Efficacy of Defibrotide and Changes in Plasma Biomarkers in Sickle Cell Disease-Related Acute Chest Syndrome (IND 127812)

[IST]

Edo Schaefer, et al.

Type: Poster

Number: 2520

Session: 114. Sickle cell Disease, Sickle Cell Trait and Other Hemoglobinopathies, Excluding Thalassemias: Clinical and Epidemiological: Poster II

Date/Time: Sunday, December 10, 6:00-8:00 PM

Abstract link

The Jazz-supported presentations at NACLC 2023 are:

Zepzelca Presentations

Presentation Title

Author

Presentation Details (All times CDT)

Real-World Use of Lurbinectedin in Patients with Small Cell Lung Cancer: Jazz EMERGE 402 Updated Analysis

Balazs Halmos, et al.

Type: Poster

Number: PP01.119

Session: Poster Viewing Reception

Date/Time: Saturday, December 2, 5:40-6:55 PM CT

Real-World Effectiveness and Safety Profile of Lurbinectedin and Other Second-Line Treatments in Small Cell Lung Cancer

Apar Ganti, et al.

Type: Poster

Number: PP01.117

Session: Poster Viewing Reception

Date/Time: Saturday, December 2, 2023/5:40-6:55 PM CT

About Zanidatamab
Zanidatamab is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

About RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn)
RYLAZE, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. RYLAZE has orphan drug designation for the treatment of ALL/LBL in the United States. RYLAZE, or recombinant Erwinia is a short-acting distinct asparaginase derived from a novel Pseudomonas fluorescens expression platform to help ensure robustness of supply to meet patient needs. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. RYLAZE was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.2

The full U.S. Prescribing Information for RYLAZE is available at:
View Source

Important Safety Information for Rylaze
RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain), which, if left untreated, may be fatal
Blood clots (may be experienced as headache, arm or leg swelling, shortness of breath, or chest pain), which may be life-threatening
Bleeding, which may be life-threatening
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea and vomiting, bone and muscle pain, infection, tiredness, headache, fever with low white blood cell count, fever, bleeding, mouth swelling (sometimes with sores), pain in the abdomen, decreased appetite, allergic reactions, high blood sugar levels, diarrhea, swelling of the pancreas, and low levels of potassium in your blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than hormonal contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of RYLAZE. For more information, ask your healthcare provider.

Call your doctor for medical advice about any side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

About Vyxeos (daunorubicin and cytarabine) liposome for injection
Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor.

In the U.S., Vyxeos (daunorubicin and cytarabine) liposome for injection is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.3

More information about Vyxeos in the United States, including Full Prescribing Information and BOXED Warning, is available here.

Important Safety Information for VYXEOS

WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products.

VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients.

VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:
shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles, or legs
unusual tiredness

VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue

VYXEOS contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS.

The most common side effects are bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

About Defitelio (defibrotide sodium)
In the U.S., Defitelio (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016, and it is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication. Defitelio is not approved for the prevention of VOD.6

Please see full Prescribing Information for Defitelio in the United States.
In Europe, defibrotide is marketed under the name Defitelio ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients after HSCT therapy. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC
(View Source)

The full Summary of Product Characteristics of Defitelio in Europe is available here.

Important Safety Information for Defitelio
Defitelio should not be given to patients who are:

Currently taking anticoagulants or fibrinolytics
Allergic to Defitelio or any of its ingredients
Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped.

Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.

Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.

The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

About Zepzelca (lurbinectedin)

Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.4

The FDA approved Zepzelca under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval is based on overall response rate (ORR) and duration of response demonstrated in an open-label, monotherapy clinical study. In December 2021, Jazz and PharmaMar announced the initiation of LAGOON, a confirmatory Phase 3 clinical trial of Zepzelca for the treatment of patients with relapsed small cell lung cancer. If positive, LAGOON could confirm the benefit of Zepzelca in the treatment of small cell lung cancer (SCLC) when patients progress following 1L treatment with a platinum-based regimen and support full approval in the U.S.

Zepzelca is a prescription medicine used to treat adults with SCLC that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.

Important Safety Information for ZEPZELCA

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.
Females who are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

What should I avoid while using ZEPZELCA?
Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.

ZEPZELCA can cause serious side effects, including:

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:

fever or any other signs of infection
unusual bruising or bleeding
tiredness
pale colored skin
Liver problems. Increased liver function tests are common with ZEPZELCA, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:

loss of appetite
nausea or vomiting
pain on the right side of your stomach area (abdomen)
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.
The most common side effects of ZEPZELCA include:

Tiredness
low white and red blood cell counts
increased kidney function blood test (creatinine)
increased liver function blood tests
increased blood sugar (glucose)
nausea
decreased appetite
muscle and joint (musculoskeletal) pain
low level of albumin in the blood
constipation
trouble breathing
low levels of sodium and magnesium in the blood
vomiting
cough
diarrhea
These are not all of the possible side effects of ZEPZELCA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here.

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.