Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Start Date01 Apr 2025

Sponsor / Collaborator

InnoPharmax, Inc.

NCT06105684 / Not yet recruitingPhase 2IIT

Phase II Single Arm Trial of Low Dose Capecitabine in Patients with Advanced Breast Cancer

This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.

Start Date01 Feb 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05314998 / Not yet recruitingPhase 3IIT

An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).

Start Date15 Jan 2025

Sponsor / Collaborator

Heidelberg University, U.S.

[+3]

100 Clinical Results associated with Capecitabine

100 Translational Medicine associated with Capecitabine

100 Patents (Medical) associated with Capecitabine

8,421

Literatures (Medical) associated with Capecitabine

01 Dec 2025·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

Author: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

01 Jan 2025·CLINICAL ONCOLOGY

Quality-of-Life Analysis of a Phase II Randomised Controlled Trial Comparing Three-Dimensional Conformal Radiotherapy and Intensity-Modulated Radiotherapy in Locally Advanced Rectal Cancer

Article

Author: Sharma, D ; McDermott, R ; Hennessy, B T ; Toomey, S ; Mahon, M ; Skourou, C ; Marron, J ; Dunne, M ; Cunningham, M ; McVey, G ; O'Sullivan, L ; Wallace, N ; Shannon, A M ; Rangaswamy, G ; Gillham, C ; Geary, R L ; O'Neill, B ; Bradshaw, S ; Parker, I ; Armstrong, J

AIMS:

Neoadjuvant radiotherapy is an integral part of the management of locally advanced rectal cancer. Radiotherapy can be delivered using three-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiotherapy (IMRT) techniques. We herein compare the quality-of-life (QOL) outcomes of patients who received radiotherapy using these techniques in a randomised trial.

MATERIALS AND METHODS:

A phase II randomised trial was conducted in patients with locally advanced rectal cancer. Patients staged as T3-4, N (any), or circumferential resection margin at risk were eligible. All patients underwent neoadjuvant chemoradiotherapy with 50.4 Gy given in 28 fractions with concomitant fluorouracil or capecitabine. Patients were randomly allocated, in a 1:1 ratio, to 3DCRT or IMRT planning techniques. QOL, a secondary objective of the study, was evaluated using the European Organisation for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and QLQ CR29 questionnaires at baseline, during the final week of radiotherapy and, at six months after radiotherapy. The impact of the treatment arm on QOL scores was evaluated using analysis of covariance after adjusting for the preintervention scores.

RESULTS:

94 patients were accrued between October 2014 and March 2020. The trial was terminated early due to futility of the primary outcome, acute gastrointestinal toxicity, at interim analysis. Eighty-six (91%) patients completed the baseline questionnaire and one other timepoint of assessment. Median follow-up was 1.9 years. Overall, both during the final week of radiotherapy and at six months, emotional functioning had improved, but physical, role, and social functionings had declined compared to that at baseline. At baseline, there was no difference in QOL scores between the two arms. During the final week of radiotherapy, the IMRT arm was associated with better adjusted mean physical (p = 0.04) and role functioning (p = 0.01) scores.

CONCLUSION:

IMRT is associated with limited QOL benefits compared to 3DCRT in patients undergoing neoadjuvant chemoradiotherapy for locally advanced rectal cancer.

01 Jan 2025·ORAL ONCOLOGY

Induction chemotherapy for locally advanced nasopharyngeal carcinoma: Efficacy and safety of the TPC regimen compared to GP and TPF

Article

Author: Zhu, XiaoDong ; Yan, Chang ; Chen, Meiwen ; Wang, Runzhi ; Liu, Fushuang ; Zhang, Chaojun ; Li, Ling ; Du, Youqing ; Lin, Guoxiang ; Qu, Song

BACKGROUND AND OBJECTIVES:

Gemcitabine plus cisplatin (GP) and docetaxel plus cisplatin plus fluorouracil (TPF) are induction chemotherapy (IC) regimens for locally advanced nasopharyngeal carcinoma (LA-NPC). The oral convenience of capecitabine presents its potential as a fluorouracil substitute in the TPF regimen, which has yet to be thoroughly investigated. This study aims to compare the efficacy and safety of the docetaxel, cisplatin, and capecitabine (TPC) with GP and TPF in LA-NPC.

METHODS:

A retrospective analysis was conducted on newly diagnosed stage III-IVa nasopharyngeal carcinoma patients who received GP, TPC, or TPF induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) between February 2019 and December 2021. A comparison of the prognostic outcomes and associated adverse reactions among patients receiving different IC regimens. Multivariate Cox regression was applied to analyze independent prognostic factors, and subgroup survival analyses were conducted based on these factors.

RESULTS:

A total of 291 LA-NPC patients were included, with 70 receiving TPC, 119 receiving GP, and 102 receiving TPF. Kaplan-Meier survival analysis indicated no significant differences in OS, PFS, LRFS, and DMFS among the 3 groups. Multivariate Cox regression identified T classification and clinical stage as independent prognostic factors. Subgroup analyses revealed no significant differences in OS and PFS between the 3 groups across T1-2 and T3-4 classifications or III and IVa stages.The TPC group exhibited lower incidence rates of treatment-related acute toxicity reactions, including grade 3-4 toxicities.

CONCLUSION:

The TPC induction chemotherapy regimen demonstrates comparable efficacy to GP and TPF, while maintaining a favorable safety profile.

322

News (Medical) associated with Capecitabine

27 Dec 2024

·pipelinereview.com

DATROWAY® Approved in Japan as the First TROP-2 Directed Therapy for Patients with Previously Treated Unresectable or Recurrent HR Positive, HER2 Negative Breast Cancer

First global approval based on TROPION-Breast01 where DATROWAY significantly reduced the risk of disease progression or death by 37% versus chemotherapy Second DXd antibody drug conjugate approved in Japan based on Daiichi Sankyo’s DXd technology TOKYO, Japan I December 27, 2024 I Daiichi Sankyo’s (TSE:4568) DATROWAY® (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. In Japan, breast cancer is the most common cancer in women.1 Approximately 92,000 cases of breast cancer were diagnosed in Japan in 2022, with approximately 17,600 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 DATROWAY is the first ever TROP-2 directed medicine to be approved in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) approved based on Daiichi Sankyo’s DXd ADC Technology. The approval of DATROWAY by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on results from the TROPION-Breast01 phase 3 trial. In this trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those treated with chemotherapy. “This first global approval of DATROWAY provides patients in Japan with metastatic HR positive, HER2 negative breast cancer a new alternative to conventional chemotherapy, which is often associated with poor response rates,” said Wataru Takasaki, PhD, Senior Advisor, Daiichi Sankyo. “DATROWAY also is the second DXd antibody drug conjugate approved in Japan based on technology invented by Daiichi Sankyo, emphasizing our commitment to creating new, innovative standards of care for patients with cancer.” In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients (including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm. The most common adverse reactions included nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%), and dry eye (21.7%). In Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY. DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in DATROWAY-treated patients. DATROWAY is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for DATROWAY therapy. Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China, U.S. and other regions. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival. Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology . TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov. About Hormone Receptor Positive, HER2 Negative Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.3 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapies are widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer.4 However, after initial treatment, further efficacy from endocrine therapy is often limited.4 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.4,5,6,7 About DATROWAY DATROWAY (datopotamab deruxtecan) is a TROP-2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP-2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY (6 mg/kg) is approved in Japan for the treatment of adult patients with HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy based on results from the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer, and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP-2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References: 1 World Health Organization. Global Cancer Observatory: Japan. Accessed December 2024. 2 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed December 2024. 3 Bray F, et al. CA Cancer J Clin. 2024; 10.3322/caac.21834. 4 Manohar P, et al. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. 5 Cortes J, et al. Lancet. 2011;377:914-923. 6 Yuan P, et al. Eur J Cancer. 2019;112:57-65. 7 Jerusalem G, et al. JAMA Oncol. 2018;4(10):1367–1374. SOURCE: Daiichi Sankyo

Phase 3Drug ApprovalADCClinical Result

23 Dec 2024

·www.businesswire.com

Puma Biotechnology’s NERLYNX® Included in NCCN Clinical Practice Guidelines for the Treatment of Cervical Cancer with a HER2 Mutation

LOS ANGELES--( BUSINESS WIRE )--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Cervical Cancer were updated to include an addition involving neratinib (NERLYNX®). The updated NCCN Practice Guidelines for Cervical Cancer include neratinib monotherapy for use as second-line or subsequent therapy for recurrent or metastatic disease as an option for patients with HER2 -mutated tumors with a designation of Category 2A. The NCCN Guidelines Category of Preference is designated as “useful in certain circumstances” as a treatment option for patients with HER2 -mutated tumors. This addition was based on results from the Phase II SUMMIT trial (NCT01953926), which enrolled a cohort of patients who were required to have histologically confirmed recurrent/metastatic cervical cancer for which no curative treatment existed, along with documented evidence of a somatic, activating HER2 mutation (Friedman CF, D'Souza A, Bello Roufai D, et al. Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the Phase II SUMMIT basket trial. Gynecol Oncol. 2024;181:162-169. doi: 10.1016/j.ygyno.2023.12.004). Alan H. Auerbach, Chief Executive Officer and President of Puma, said, “We are pleased with the additional inclusion of neratinib in the NCCN Guidelines for Cervical Cancer for patients with HER2 activating mutations. Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients. We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced cervical cancer.” About HER2-Mutated Cervical Cancer Despite recent advancements in the therapeutic landscape for recurrent and metastatic cervical cancer, there is a need to identify robust biomarkers to direct therapy choices to target mutational drivers. Somatic HER2 (ERBB2) mutations have been reported in up to 9% 1,2,3 of cervical cancers and are associated with poor prognosis 1,2 . In a recent real-world study, prospective genomic profiling of cervical cancer patients identified HER2 mutations as one of the more prevalent genomic alterations in the studied cervical cancer population 3 . About the National Comprehensive Cancer Network The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https://www.NERLYNX.com or by dialing 1-855-816-5421. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com . INDICATIONS NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting. Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication CONTRAINDICATIONS: None WARNINGS AND PRECAUTIONS: Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction. Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities. Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS : The most common adverse reactions (reported in ≥ 5% of patients) were as follows: NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection. NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . DRUG INTERACTIONS: Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids. Strong CYP3A4 inhibitors: Avoid concomitant use. P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use. Strong or moderate CYP3A4 inducers: Avoid concomitant use. Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX. USE IN SPECIFIC POPULATIONS : Lactation: Advise women not to breastfeed. Please see Full Prescribing Information for additional safety information. 1 Xiang L, Jiang W, Ye S, He T, Pei X, Li J, et al. ERBB2 mutation: A promising target in non-squamous cervical cancer. Gynecol Oncol . 2018;148(2):311-316. 2 Zammataro L, Lopez S, Bellone S, Pettinella F, Bonazzoli E, Perrone E, et al. Whole-exome sequencing of cervical carcinomas identifies activating ERBB2 and PIK3CA mutations as targets for combination therapy. Proc Natl Acad Sci U S A . 2019;116(45):22730-22736. 3 Friedman CF, Ravichandran V, Miller K, et al. Assessing the genomic landscape of cervical cancers: clinical opportunities and therapeutic targets. Clin Cancer Res . 2023;29(22):4660-4668. doi: 10.1158/1078-0432.CCR-23-1078. PMID: 37643132; PMCID: PMC10644000.

Phase 2Drug ApprovalLicense out/inClinical Result

13 Dec 2024

·endpts.com

Eisai subsidiary nabs Japan rights for schizophrenia drug; Novavax's $50M milestone

Plus, news about Candel, Inovio and RemeGene: Eisai licenses Newron Pharmaceuticals’ evenamide: Eisai’s subsidiary EA Pharma will pay up to €117 million ($123 million) in upfront and milestone fees for rights to the treatment-resistant schizophrenia therapy in Japan and other Asian territories. Newron will continue development elsewhere, with a pivotal trial of the glutamate modulator as an add-on therapy to antipsychotics to start next year. — Elizabeth Cairns Novavax earns a milestone: The Maryland vaccine maker received the first $50 million biobuck payment from Sanofi as part of the pact they announced in May . — Kyle LaHucik Candel priced its $80 million offering at $6 per share $CADL following Phase 3 data earlier this week, and Inovio priced its $30 million offering to fund its DNA medicines. — Kyle LaHucik RemeGen’s ADC succeeds in Phase 3 : Data presented at the San Antonio Breast Cancer Symposium showed disitamab vedotin yielded a 44% reduction in the risk of progression or death in patients with HER2-positive advanced breast cancer with liver metastasis, versus Novartis’ Tykerb plus capecitabine. Progression-free survival with the HER2-targeting conjugate was 9.9 months versus 4.9 months with the Tykerb combo. The company described the PFS benefit as “clinically meaningful”. — Elizabeth Cairns

VaccinePhase 3Clinical Result

100 Deals associated with Capecitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D01223	Capecitabine	L01BC06	DB01101

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Gastrooesophageal junction cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Pancreatic Cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Rectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	19 Sep 2016
Esophageal Carcinoma	AU	Dr. Reddy's Laboratories (Australia) Pty Ltd.	24 Jun 2013
Locally advanced breast cancer	EU	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	EU	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	EU	KRKA dd	20 Apr 2012
Locally advanced breast cancer	IS	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	IS	KRKA dd	20 Apr 2012
Locally advanced breast cancer	IS	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	LI	KRKA dd	20 Apr 2012
Locally advanced breast cancer	LI	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	LI	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	KRKA dd	20 Apr 2012
Locally advanced breast cancer	NO	Accord Healthcare SLU	20 Apr 2012
Stomach Cancer	CN	Chugai Pharmaceutical Co., Ltd.	17 Oct 2008
Breast cancer recurrent	JP	CHEPLAPHARM Arzneimittel GmbH	12 Dec 2007
Colonic Cancer	JP	Chugai Pharmaceutical Co., Ltd.	30 Apr 2003
Advanced gastric carcinoma	EU	CHEPLAPHARM Arzneimittel GmbH	02 Feb 2001

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic gastric adenocarcinoma	Phase 3	US	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	JP	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	AR	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	BE	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CA	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CZ	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	DK	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	FI	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	FR	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	DE	Eli Lilly & Co.	20 Jan 2015

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03329248 (QUILT-3.060, CTgov)	Phase 1/2	Pancreatic Cancer	6	SBRT+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+nab-paclitaxel+cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	yurvglrccf(oafbougvis) = puevaqxsde gpypljdfoe (ammiworjte, djkheibasf - zlzryfukmk) View more	-	12 Dec 2024
NCT04324476 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	52	CAPOX/CAPIRI plus bevacizumab	zzjwxthsvp(ijyqmfpngt) = yxvkzcqubx frcmuswibe (wxueudbxtk, 9.0 - 12.4) View more	Positive	11 Dec 2024
NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	hfrfwwgitz(kvlieojllc) = odlvfblkrk vgrtitplwe (esjuuldhne, efnwxuafnw - kecoxtcmrm) View more	-	11 Dec 2024
				Regorafenib (Regorafenib)	cmfwcsmxxs(rqlivipwde) = zjvphlyhdk bhuuotctab (uknvyujnyb, wjotxawatz - rjmstcspvn) View more
ESMO_ASIA2024	Not Applicable	Head and Neck Neoplasms	101	Capecitabine 2000 mg + Cyclophosphamide 100 mg	tgoddvpyoo(anlfjbfuec) = most patients experiencing manageable Grade 1 mucositis ztcarmstyx (bpkwxxkhzr )	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Colorectal Cancer	214	capecitabine (Age ≥60 years)	sbrpbmbghb(arpqinjjrz) = suvfqcxpdw kaskkhvhfi (zfzdmnxwfd )	-	07 Dec 2024
				Capecitabine monotherapy	sbrpbmbghb(arpqinjjrz) = luenmzggin kaskkhvhfi (zfzdmnxwfd )
NCT03487666 (CTgov)	Phase 2	Triple Negative Breast Cancer	45	Nivolumab (Arm A- Nivolumab)	cogfwxdhra(lueuaducul) = aawafhatya piagmapqpw (knqiupixio, pdyxazqqsv - prnhmqskeh) View more	-	03 Dec 2024
				Capecitabine (Arm B- Capecitabine)	cogfwxdhra(lueuaducul) = ddjzqvkbud piagmapqpw (knqiupixio, zvbudzzxgs - fmcjfghcxc) View more
NCT03259035 (CCTG CO.28 \| NEO \| CO.28, CTgov)	Phase 2	Rectal Cancer	58	folinic acid+oxaliplatin+capecitabine+fluorouracil	qrcusjcezc(bhrodihafx) = enfstgpehw uomqbehzsz (mevymfgghv, emyculhdmz - cxtgjxqgcf) View more	-	10 Oct 2024
NCT03691051 (PERMEATE, Pubmed \| EClinicalMedicine) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	78	Pyrotinib plus capecitabine	hncncwtofv(vzgjumcbfi) = lpjemdtkpt bmukglmhjh (weilmlqbqi, 24.4 - not reached) View more	Positive	01 Oct 2024
				Pyrotinibcapecitabine (Radiotherapy-naïve brain metastases)	hncncwtofv(vzgjumcbfi) = otvtioizps bmukglmhjh (weilmlqbqi, 12.6 - 33.3) View more
ASTRO2024	Not Applicable	Breast Cancer	-	Concurrent chemoradiotherapy with capecitabine 1000mg/m2 bid	xlcdztmxxo(cdazosmjtd) = None but 1 patient discontinued concurrent medication because of gastrointestinal reaction pmgsiigahb (pkevdhvdww ) View more	-	01 Oct 2024
				Low-dose maintenance therapy with capecitabine 500mg tid
NCT02767661 (MECCA, ESMO2024) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer First line Hormone Receptor Positive \| HER2 Negative	254	Metronomic capecitabine plus aromatase inhibitor	vmltwjeccb(yysqvprdkk) = blskurddsc hjlvsuzirq (fzirgfysac ) View more	Positive	16 Sep 2024
				Aromatase inhibitor alone	vmltwjeccb(yysqvprdkk) = tipuinhini hjlvsuzirq (fzirgfysac ) View more

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