RegulationConditional marketing approval (CN), Special Review Project (CN), Fast Track (US), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (CN)

Structure

Molecular FormulaC19H20N4O

InChIKeyPCHKPVIQAHNQLW-CQSZACIVSA-N

CAS Registry1038915-60-4

View All Structures (2)

237

Clinical Trials associated with Niraparib Tosylate

NCT06412120 / Not yet recruitingPhase 4IIT

Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry

The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06682780 / Not yet recruitingPhase 1/2

An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

Start Date05 Dec 2024

Sponsor / Collaborator

LaNova Medicines Ltd.

NCT05460000 / RecruitingPhase 2IIT

A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy (N-Plus)

Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.

Start Date25 Nov 2024

Sponsor / Collaborator

North Eastern German Society of Gynaecological Oncology

[+1]

100 Clinical Results associated with Niraparib Tosylate

100 Translational Medicine associated with Niraparib Tosylate

100 Patents (Medical) associated with Niraparib Tosylate

611

Literatures (Medical) associated with Niraparib Tosylate

31 Dec 2024·Journal of Pharmaceutical Policy and Practice

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Article

Author: Naci, Huseyin ; Dottino, Joseph A ; Esselen, Katharine M ; Shahzad, Mahnum ; Wagner, Anita K

BackgroundWithdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited pathways. In this paper, we focus on three poly-ADP-ribose polymerase inhibitors (olaparib, rucaparib and niraparib) for the treatment of women with heavily pretreated, recurrent ovarian cancer, which were eventually withdrawn.MethodsWe use a comparative case study approach to evaluate the regulatory histories of these drug indications in the US and Europe.ResultsTwo drug indications benefited from the FDA's accelerated approval pathway, which explicitly lowers the bar for evidence of efficacy at the time of approval. Following accelerated approval, manufacturers are mandated to conduct post-marketing studies to confirm clinical benefit. The FDA granted accelerated approval to olaparib and rucaparib based on data on surrogate endpoints and converted the approval to regular approval after the submission of additional data on surrogate endpoints from one of two required confirmatory trials, that is, without data on clinical benefit. Niraparib directly received regular approval based only on data on a surrogate endpoint. By contrast, the EMA granted conditional marketing authorisation to rucaparib and was quicker to restrict usage than the FDA.ConclusionThe regulatory histories of these drug indications highlight the need to reform the accelerated approval pathway by ensuring that post-marketing requirements are followed, and that regular approval is only based on evidence of clinical benefit.

01 Dec 2024·Biochemistry and Biophysics Reports

Comparison of two-dimensional and three-dimensional culture systems and their responses to chemotherapy in cells representing disease progression of high-grade serous ovarian cancer

Article

Author: Telleria, Carlos M. ; Forgie, Benjamin N. ; Prakash, Rewati ; Goyeneche, Alicia A. ; Abdalbari, Farah H. ; Abdalbari, Farah H ; El Mokbel, Naya ; Telleria, Carlos M ; Zeng, Xing ; Annie Leung, Shuk On ; Tessier-Cloutier, Basile ; Forgie, Benjamin N ; Goyeneche, Alicia A

High-grade serous cancer is the most common type of ovarian cancer and is usually diagnosed at advanced stages with high mortality due to recurrence and eventual resistance to standard platinum therapy. The aim of this study was to compare two-dimensional (2D) versus tridimensional (3D) cell culture as a preclinical model of response to carboplatin, paclitaxel and niraparib using PEO1, PEO4 and PEO6 cell lines, which were generated from the same patient along disease progression. Morphologically, cells formed flat adherent layers versus spheroidal structures with different compaction patterns in 2D and 3D respectively. In 2D, apoptosis was rare whereas in 3D cells formed a multilayered structure with an outer layer of live proliferating cells and an inner core of apoptotic cells. Furthermore, a differential capacity to produce ATP was observed among the cell lines in 3D but not in 2D. While response to carboplatin, paclitaxel and niraparib in both settings followed a similar trend, a lower sensitivity was observed in 3D with respect to 2D. Overall, 3D cell culture is likely more reflective of the in vivo cellular tumor behavior and more suitable of therapeutic evaluation given its added complexity absent in 2D.

01 Dec 2024·European Journal of Medicinal Chemistry

Isoxazole compounds: Unveiling the synthetic strategy, in-silico SAR & toxicity studies and future perspective as PARP inhibitor in cancer therapy

Review

Author: Malik, Udita ; Pal, Dilipkumar

Latest developments in cancer treatment have shed a light on the crucial role of PARP inhibitors that enhance the treatment effectiveness by modifying abnormal repair pathways. PARP inhibitors, such as Olaparib, Rucaparib, Niraparib, and Talazoparib have been approved in a number of cancers including BRCA 1/BRCA2 associated malignancies although there are many difficulties as therapeutical resistance. Besides the conventional synthetic drugs, natural compounds such as flavones and flavonoids have been found to be PARP inhibitors but only in preclinical studies. Isoxazole is very important class of potential candidates for medicinal chemistry with anti-cancer and other pharmacological activities. At present, there are no approved PARP inhibitors of isoxazole origin but their ability to hit many pathways inside the cancer cells points out on its importance for future treatments design. In drug development, isoxazoles are helpful because of the molecular design flexibility that may be enhanced using various synthetic approaches. This review highlights the molecular mechanisms of PARP inhibition, importance of isoxazole compounds and present advances in their synthetic strategies that demonstrate promise for these agents as new anticancer drugs. It emphasizes that isoxazole-based PARP inhibitors compounds could be novel anti-cancer drugs. Through this review, we hope to grow a curiosity in additional explorations of isoxazole-based PARP inhibitors and their applications in the trends of novel insights towards precision cancer therapy.

203

News (Medical) associated with Niraparib Tosylate

04 Nov 2024

·www.prnewswire.com

IDEAYA Biosciences, Inc. Reports Third Quarter 2024 Financial Results and Provides Business Update

Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential Ph2/3 registration-enabling trial is ahead of schedule and has exceeded 150 patients Successful FDA Type C meeting and targeting initiation of Ph3 registration-enabling trial for darovasertib in neoadjuvant UM in H1 2025; Phase 2 neoadjuvant update with ~49% with >30% ocular tumor shrinkage & ~61% eyes preserved, and over 75 patients enrolled ENA 2024: Late-breaker oral presentation of IDE397 in MTAP-deletion UC and NSCLC with confirmed ORR by RECIST 1.1 of 40%, 38%, and 22%, in UC, SqNSCLC, and AdenoNSCLC, respectively; co-published IDE397 + AMG 193 preclinical combo data in MTAP-deletion IDE397 + AMG 193 combination study ongoing in MTAP-deletion solid tumors, and targeting expansion in MTAP-deletion NSCLC in late 2024 to early 2025 Targeting expansion of Phase 1/2 study of IDE397 in combination with Trodelvy® in MTAP-deletion UC in Q4 2024, and PR reported at ENA 2024 has confirmed by RECIST 1.1 Targeting Phase 1/2 expansion for IDE161 and FPI in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in MSI-High and MSS EC in Q4 2024 IDE705 (GSK 101) Pol Theta Helicase Phase 1 dose escalation ongoing in HRD solid tumors Received IND clearance for IDE275 (GSK959) Werner Helicase development candidate ($7.0 million milestone) for Phase 1 trial in MSI-High solid tumors Targeting Development Candidate nomination for MTAP-deletion, KAT6 pathway and B7H3/PTK7 Topo-Payload Bispecific-ADC programs in Q4 2024 Targeting Investor R&D Day on Monday, December 16, to highlight IDEAYA's preclinical and clinical pipeline with leading KOL(s) and Pharma partner(s) $1.2 billion of cash, cash equivalents and marketable securities as of September 30, 2024, anticipated to fund operations into at least 2028; Completed an oversubscribed ~$302.4 million follow-on financing in July 2024 SOUTH SAN FRANCISCO, Calif., Nov. 4, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update, and announced financial results for the third quarter ended September 30, 2024. "This was a transformational quarter for IDEAYA, including completion of an oversubscribed ~$302.4 million follow-on financing, a late breaker oral presentation at ENA 2024 for IDE397 in heavily pre-treated MTAP-deletion urothelial and lung cancer patients, and a successful Type C meeting with the FDA to enable a potential registration-enabling trial for darovasertib in neoadjuvant uveal melanoma. Next, we received IND clearance for Werner Helicase inhibitor IDE275 with our partner GSK, representing our fifth potential first-in-class clinical program," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences. "We continue to execute on our strategic vision to build a leading precision medicine oncology pipeline, and are on track to nominate our 6th, 7th, and 8th development candidate by year-end, including from our B7H3/PTK7 bi-specific topo-ADC, MTAP-deletion, and KAT6 pathway programs. We look forward to highlighting IDEAYA's potential first-in-class preclinical and clinical programs, and to continue to establish our scientific leadership in precision medicine oncology at our upcoming investor R&D day," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences. "This past quarter, we made significant progress on the darovasertib program, including being ahead of our enrollment targets for the first-line MUM potential registration-enabling trial, and a successful Type C meeting with the FDA to inform a potentially registration-enabling trial in the neoadjuvant uveal melanoma setting. Next, the clinical data update from ENA 2024, provides further clinical proof-of-concept for IDE397 at the RP2D in MTAP-deletion urothelial and lung cancer. We are excited to advance our broader IDE397 rational combination strategy, including target expansion with AMG 193 in MTAP-deletion NSCLC in late 2024 to early 2025, and target expansion with Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2 directed antibody-drug conjugate, in MTAP-deletion urothelial cancer in the fourth quarter. Lastly, we are targeting to select a monotherapy expansion dose for IDE161, and achieve FPI in combination with Keytruda in MSI-High and MSS endometrial cancer by year-end," added Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. Summary of Q3 and Recent Key Developments Research and Clinical Development Darovasertib in 1L MUM and Neoadjuvant Uveal Melanoma (UM) Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential Ph2/3 registration-enabling trial is ahead of schedule and has exceeded 150 patients Positive interim Phase 2 results of darovasertib (IDE196) from the company-sponsored and investigator-sponsored trials (IST) were highlighted during an Investor Webcast in September 2024, and over 75 patients have been enrolled in company-sponsored trial. Following a successful Type C meeting with the U.S. Food and Drug Administration (FDA), IDEAYA is finalizing the Phase 3 registrational trial protocol and is targeting to initiate its potential registration-enabling trial in the first half of 2025. IDE397 in MTAP-Deletion Solid Tumors Phase 1 expansion results of IDE397 in 27 evaluable MTAP-deletion urothelial cancer (UC) and non-small cell lung cancer (NSCLC) patients were presented as a late-breaking oral presentation at the 36th EORTC-NCI-AACR Symposium (ENA 2024) in Barcelona, Spain. Additional preclinical data on the anti-tumor activity by combinatorial inhibition of IDE397 and clinical stage PRMT5 inhibitors AMG 193 and BMS-986504 in MTAP-deleted tumors were included in a poster presentation. Reported positive interim data from 18 evaluable MTAP-deletion UC and NSCLC patients and selected the move-forward Phase 2 expansion dose (RP2D) in an Investor Webcast in July 2024. Enrollment is ongoing in the IDE397 and AMG 193 Phase 1 dose escalation, and targeting expansion in NSCLC in late 2024 to early 2025. Ongoing Phase 1 trial evaluating IDE397 in combination with Trodelvy in MTAP-deletion UC; targeting combination expansion in the fourth quarter of 2024. The PR reported at ENA 2024 has confirmed by RECIST 1.1. IDE161 in Tumors with Homologous Recombination Deficiency Targeting Phase 1/2 monotherapy expansion for IDE161 PARG inhibitor in priority solid tumor type(s) in the fourth quarter of 2024. Targeting first-patient-in for the Phase 1 trial evaluating IDE161, IDEAYA's first-in-class potential PARG inhibitor, in combination with Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in MSI-High and MSS endometrial cancer (EC) in the fourth quarter of 2024. Preclinical data on IDE161 and antibody drug conjugate (ADC) combination rationale presented as a poster at ENA 2024. Received FDA IND clearance for IDE275 (GSK959), a potential first-in-class and best-in-class Werner Helicase inhibitor, for a Phase 1 trial in high microsatellite instability (MSI-High) tumors and earned a $7.0 million milestone from GSK. Targeting Development Candidate nomination for MTAP-deletion, KAT6 pathway and B7H3/PTK7 Topo-Payload Bispecific-ADC programs in the fourth quarter of 2024. IDEAYA is targeting to host a Virtual Investor R&D Day on Monday, December 16, 2024, to highlight IDEAYA's potential first-in-class preclinical and clinical pipeline with management, leading Key Opinion Leader(s) (KOLs), and Pharma partner(s). Corporate Development Raised gross proceeds of approximately $302.4 million in July 2024 through public offering, generating net proceeds of approximately $283.8 million. Appointed Douglas B. Snyder as Senior Vice President, General Counsel. Mr. Snyder brings over 25 years of legal experience with leading healthcare organizations, including GW Pharmaceuticals, Actelion Pharmaceuticals, Eisai, GSK, and the U.S. FDA. Clinical Programs and Upcoming Milestones Darovasertib (IDE196) Program in Tumors with GNAQ or GNA11 Mutations Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM. Darovasertib is currently being evaluated in four ongoing clinical trials. The darovasertib and crizotinib combination in MUM has FDA Fast Track designation: IDE196-002 (NCT05987332) is a Phase 2/3 potentially registration-enabling clinical trial of darovasertib + crizotinib in first-line human leukocyte antigens (HLA)-A2*02:01 negative (-) MUM. Over 150 patients enrolled as of October 31, 2024. IDE196-001 (NCT03947385) is a Phase 1/2 clinical trial of darovasertib + crizotinib in which we are planning to enroll additional HLA-A2*02:01 positive (+) patients. Phase 2 trials of darovasertib as neoadjuvant / adjuvant therapy in primary UM: IDE196-009 (NCT05907954) is a company-sponsored Phase 2 trial evaluating darovasertib as neoadjuvant treatment of UM prior to primary interventional treatment of enucleation or radiation therapy, and as adjuvant therapy following the primary treatment. Over 75 patients enrolled as of October 31, 2024. NADOM (NCT05187884) is a Phase 2 neoadjuvant / adjuvant trial of darovasertib in ocular melanoma. This is an IST led by Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital in Sydney with additional participating sites in Melbourne, Australia. Positive interim efficacy data from both the company-sponsored and the IST trials were highlighted during an Investor webcast in September 2024: 31 enucleation and 18 plaque brachytherapy evaluable UM patients treated with darovasertib neoadjuvant therapy in Phase 2 company-sponsored and IST trials. ~59% (29 of 49) of patients with >20% ocular tumor shrinkage by product of diameters. ~49% (24 of 49) of patients with >30% ocular tumor shrinkage by product of diameters. ~61% (19 of 31) eye preservation rate observed. Evidence of predicted visual preservation observed by reducing the amount of radiation associated with plaque brachytherapy. Manageable AE profile observed from Phase 2 company-sponsored trial (n=38), including 11% grade 3 or higher AEs, and 5% serious AE rate. The discontinuation rate observed was 3%. The most common AEs observed included diarrhea, nausea, vomiting and fatigue. IDEAYA had a successful Type C meeting with the FDA to discuss the clinical trial design for a registration-enabling Phase 3 trial in neoadjuvant UM patients. The planned trial aims to enroll approximately 400 patients in two cohorts: cohort 1 of plaque brachytherapy eligible UM patients, and cohort 2 of enucleation eligible UM patients. Cohort 1 will be randomized to darovasertib followed by plaque brachytherapy versus plaque brachytherapy alone, and cohort 2 will be randomized with or without darovasertib as neoadjuvant therapy. The primary endpoint of the trial is planned to be time to vision loss and eye preservation rate for cohort 1 and 2, respectively. The secondary endpoint for the trial is no detriment to Event-Free-Survival (EFS). Discussions with the FDA are ongoing regarding surrogate and composite endpoints to support earlier approval scenarios. IDEAYA is currently finalizing the trial protocol and is targeting to initiate the potential Phase 3 registration-enabling study in the first half of 2025. IDE397 Program in Tumors with MTAP Deletion IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. IDEAYA continues to evaluate IDE397 in two trials in select monotherapy indications and in high conviction clinical combinations: IDE397-001 (NCT04794699) is a Phase 1/2 treatment study with a monotherapy expansion in MTAP-deletion UC and NSCLC. The estimated U.S. MTAP-deletion annual incidence in UC and NSCLC is approximately 48,000 patients. Encouraging clinical activity at the 30 mg once-a-day Phase 2 monotherapy expansion dose was observed in the Phase 1 clinical trial evaluating IDE397 in heavily pre-treated MTAP-deletion UC and NSCLC patients presented at ENA 2024 in October 2024. The patients evaluated had a median of two to three prior lines-of-therapy, ranging from one to seven. The reported Phase 1 clinical expansion data was based on 27 evaluable MTAP-deletion patients, including 10 UC, nine adenocarcinoma (Adeno) NSCLC, and eight squamous (Sq) NSCLC patients at the expansion dose of 30 mg once-a-day of IDE397 : ~33% Overall Response Rate (ORR). One complete response (CR) and eight partial responses (PRs) by RECIST 1.1 evaluation out of 27 evaluable patients. Nine of nine responses have been confirmed by RECIST 1.1, including four UC patients, of which one was a CR, three squamous NSCLC patients, and two adenocarcinoma NSCLC patients. Two patients confirmed after the data cutoff date. In the earlier reported July 8, 2024, IDE397 webcast program update, five confirmed responses were reported out of 18 evaluable MTAP-deletion UC and NSCLC patients by RECIST 1.1. There were zero non-evaluable patients reported as of the data analysis. Confirmed ORR% by RECIST 1.1 by Solid Tumor Type: MTAP-deletion UC = 40% (4 of 10) confirmed ORR%; MTAP-deletion squamous NSCLC = ~38% (3 of 8) confirmed ORR%; MTAP-deletion adenocarcinoma NSCLC = ~22% (2 of 9) confirmed ORR%. Multiple confirmed partial responses by RECIST 1.1 harbor genetic co-alterations, including MTAP-deletion and KRAS G12D mutation in NSCLC, and MTAP-deletion and FGFR-TACC3 fusion in UC. ~93% Disease Control Rate (DCR). One CR, eight PRs, and 16 stable disease (SD) by RECIST 1.1 evaluation out of 27 evaluable patients. Preliminary durability assessment: 15 of 27 patients still on treatment. Seven of nine RECIST 1.1 responses remain on treatment. Median duration of treatment (DOT) has not been reached and is greater than 6.2 months and median time to response (TTR) is ~2.7 months. The median duration of response and median progression free survival data is still immature. Three UC patients on treatment greater than 250 days, four squamous NSCLC patients on treatment greater than 200 days, and three adenocarcinoma NSCLC patients on treatment greater than 200 days ~81% circulating tumor DNA (ctDNA) Molecular Response Rate (MRR). 17 of 21 patients with 50% or greater ctDNA reduction, and ~33% (7 of 21) with deep 90% or greater ctDNA reduction. All MRs (17 of 17) were rapid occurring at the first ctDNA sample analysis. There were several quality control failures of patient samples that led to unavailability for MR analysis Favorable adverse event (AE) profile. Approximately 18% grade 3 or higher drug-related AEs and no drug-related serious adverse events (SAEs) observed at the IDE397 30mg once-a-day expansion dose. No drug-related AEs leading to discontinuations were observed. We anticipate that the favorable AE profile and dosing convenience of a 30 mg once-a-day tablet has the potential to enable long-term dosing and combination development, including with MTA-cooperative PRMT5 inhibitors and topoisomerase payload antibody drug conjugates (ADCs) Over 35 global clinical trial sites activated in the U.S., Canada, Europe and Asia Pasic to enable rapid enrollment. Targeting development of IDE397 registrational plan in MTAP-deletion solid tumors in 2025. Phase 1/2 trial of IDE397 and AMG 193 in MTAP-Deletion NSCLC (Amgen-sponsored study, NCT05975073) Preclinical poster presentation on the antitumor activity by combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors presented at ENA 2024. Enrollment is ongoing in the IDE397 and AMG193 Phase 1 dose escalation. Targeting expansion in NSCLC in late 2024 to early 2025. Phase 1 trial of IDE397 and Trodelvy in MTAP-deletion UC (IDEAYA-sponsored, NCT04794699) evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy is ongoing. Reported the first preliminary clinical case study of the IDE397 and Trodelvy combination in MTAP-deletion UC at ENA 2024, including a PR by RECIST 1.1 in a patient case report with a genetic co-alteration of MTAP-deletion and a FGFR3-TACC3 fusion, and rapid and deep first-evaluation molecular responses with ctDNA reduction of greater than 95% observed. The PR reported at ENA 2024 has now confirmed by RECIST 1.1. Targeting to initiate the IDE397 and Trodelvy Phase 1/2 combination expansion in MTAP-deletion UC in Q4 2024. Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA. IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established. IDE161 Program in Tumors with Homologous Recombination Deficiency IDE161 is a potential first-in-class inhibitor of poly(ADP-ribose) glycohydrolase (PARG), a novel, mechanistically distinct target in the same clinically validated biological pathway as poly(ADP-ribose) polymerase (PARP). IDE161 received two FDA Fast Track designations in platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations, and in pretreated advanced or metastatic HR+, Her2-, BRACA1/2 mutant breast cancer. IDE161 is currently being evaluated in IDE161-001 (NCT05787587), a Phase 1 trial of IDE161 monotherapy in solid tumors with homologous recombination deficiency (HRD) and in the planned combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in microsatellite instability high (MSI-High) and microsatellite stable (MSS) endometrial cancer. Selection of an initial Phase 1/2 IDE161 monotherapy expansion dose in priority solid tumors type(s) is targeted in the fourth quarter of 2024. Separately, a first-patient-in for IDE161 in combination with KEYTRUDA is targeted in the fourth quarter of 2024. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. In addition, preclinical results on IDE161 and ADC combination rationale were presented as a poster at ENA 2024. GSK-Partnered Programs IDE705 (GSK101) Program in Tumors with HRD IDE705 (GSK101) is a potential first-in-class small molecule inhibitor of Pol Theta Helicase being developed as a combination treatment with niraparib for advanced solid tumors with HRD. The dose escalation portion of the GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 in combination with niraparib, the GSK small molecule inhibitor of PARP, for patients having solid tumors with BRCA or other HR mutations, or with HRD is currently ongoing. Upon initiation of the Phase 1 dose expansion, IDEAYA will be eligible to receive a $10.0 million milestone payment, with the collaboration having potential further aggregate later-stage development and regulatory milestones of up to $465.0 million. GSK is responsible for all research and development costs for the program. Upon commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones, and tiered royalties on global net sales of GSK101 – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions. IDE275 (GSK959) Program in Tumors with MSI-High IDE275 (GSK959) is a potential first-in-class Werner helicase inhibitor that received FDA IND clearance for a Phase 1 trial in October 2024. The GSK-sponsored Phase 1 trial will evaluate IDE275 (GSK959) in patients having MSI-High tumors, as a monotherapy and in combination with a PD-1 inhibitor. IDEAYA earned a $7 million milestone payment for the IND clearance and has the potential to earn up to an additional $10.0 million upon initiation of Phase 1 clinical dose expansion. In addition, IDEAYA is entitled to receive up to $465.0 million in further later-stage development and regulatory milestones. GSK is responsible for 80% of global research and development costs and IDEAYA is responsible for 20% of such costs. Upon commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones, 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of the Werner Helicase inhibitor development candidate (DC) – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions. B7H3/PTK7 Topo-Payload BsADC Program IDEAYA entered into an option and license agreement for a potential first-in-class B7H3/PTK7 Topo-Payload BsADC program with Biocytogen in July 2024. The agreement grants IDEAYA an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 Topo-Payload BsADC program. B7H3/PTK7 has been found to be co-expressed in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others. Based on preclinical data, the potential first-in-class B7H3/PTK7 Topo-Payload BsADC program has the potential to be developed as a monotherapy agent and used in combination with multiple programs in IDEAYA's pipeline targeting DDR-based therapies, including the PARG inhibitor IDE161. A development candidate nomination for the B7H3/PTK7 Topo-Payload BsADC program is targeted in the fourth quarter of 2024. Next-Generation Precision Medicine Pipeline Programs Early preclinical research programs focused on pharmacological inhibition of several new targets for patients with solid tumors characterized by defined biomarkers based on genetic mutations and/or molecular signatures are ongoing. These programs have the potential for discovery and development of first-in-class or best-in-class therapeutics with multiple wholly owned DC nominations targeted in the fourth quarter of 2024, including in MTAP-deletion solid tumors indications to enable a potential wholly-owned clinical combination with IDE397, and separately a DC nomination in the lysine acetyltransferase 6 (KAT6) pathway. Financial Results As of September 30, 2024, IDEAYA had cash, cash equivalents and marketable securities totaling $1.2 billion. This compared to cash, cash equivalents and marketable securities of $952.7 million as of June 30, 2024. The increase was primarily attributable to $283.8 million in net proceeds from the underwritten public offering of common stock and pre-funded warrants to purchase common stock in July 2024, partially offset by net cash used in operations. Research and development (R&D) expenses for the three months ended September 30, 2024 totaled $57.2 million compared to $54.5 million for the three months ended June 30, 2024. The increase was primarily due to clinical trial and outside services expenses. General and administrative (G&A) expenses for the three months ended September 30, 2024 totaled $9.7 million compared to $10.4 million for the three months ended June 30, 2024. The decrease was primarily due to stock-based compensation expense. The net loss for the three months ended September 30, 2024 was $51.8 million compared to the net loss of $52.8 million for the three months ended June 30, 2024. Total stock compensation expense for the three months ended September 30, 2024 was $9.2 million compared to $9.7 million for the three months ended June 30, 2024. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: . Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing, content and venue of clinical program updates, (ii) the timing of expansion of Phase 1/2 trial of IDE397 in combination with Trodelvy® in MTAP-deletion UC, (iii) the timing of expansion of Phase 1 trial of IDE397 in combination with AMG 193 in NSCLC, (iv) the timing of finalization of Phase 3 registration trial protocol and initiation of trial for darovasertib, (v) the timing of a first-patient-in in the IDE161 and KEYTRUDA combination study, (vi) the timing of DC nominations for MTAP-deletion, KAT6 pathway and B7H3/PTK7 Topo-Payload Bispecific-ADC programs, (vii) the timing of designation of next generation development candidates, (viii) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations, (ix) the estimate of patient populations, (x) additional clinical combinations, and (xi) the receipt of development and regulatory milestones. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Andres Ruiz Briseno SVP, Head of Finance and Investor Relations [email protected] SOURCE IDEAYA Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultFinancial StatementFast Track

14 Sep 2024

·www.fiercepharma.com

ESMO: GSK's Zejula misses survival goal in first-line ovarian cancer, as pharma&'s combo disappoints

The PARP inhibitor class, featuring drugs from GSK, AstraZeneca/Merck and pharma&, has faced serious regulatory setbacks before this pair of clinical disappointments. In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. Another study showed that pharma&’s attempt to enhance its Rubraca with Bristol Myers Squibb’s Opdivo seriously backfired.GSK’s Zejula boasts a broad U.S. approval as a first-line maintenance treatment for ovarian cancer patients who have responded to initial platinum-based chemotherapy. But the phase 3 study that earned the drug that approval, PRIMA, has now shown at its final analysis that Zejula didn’t extend patients’ lives compared with placebo.After a median follow-up of about 74 months, patients in the PRIMA trial who took Zejula as a first-line maintenance treatment were essentially as likely to die as those who received placebo. In fact, Zejula was linked to a 1% higher risk of death, as Zejula takers lived a median 46.6 months, versus 48.8 months for control, according to results presented at the European Society for Medical Oncology (ESMO) 2024 annual meeting.The negative overall survival showing, however marginal, raises the possibility of an FDA crackdown like the one the agency waged on the PARP inhibitor class about two years ago. At that time, several later-line ovarian cancer indications for Zejula, AstraZeneca and Merck’s Lynparza, and the then-Clovis Oncology-owned Rubraca were withdrawn or restricted after the FDA noted a potential long-term detriment to patient survival. Zejula’s OS readoutThe risk of death in PRIMA only turned against Zejula after a small group of patients with undetermined status on the homologous-recombination biomarker were counted, GSK’s global head of oncology R&D, Hesham Abdullah, M.D., noted in an interview with Fierce Pharma. Zejula was associated with a positive 5% reduction in the risk of death in patients with homologous recombination-deficient (HRd) tumors and a 7% improvement in the homologous recombination-proficient (HRp) population. None of the above numbers carry statistical significance.Zejula secured its FDA approval for the first-line maintenance treatment of ovarian cancer—regardless of biomarker status—in 2020 after the PRIMA trial demonstrated that the drug could reduce the risk of disease progression or death by 38% versus placebo. At the time, the biggest benefit was seen in those with BRCA mutations, followed by other HRd types, then HRp tumors, with those with undetermined biomarker status experiencing the least benefit.More therapies have emerged for ovarian cancer since the PRIMA trial, and the overall survival analysis was likely confounded by the use of subsequent therapies, Abdullah said. About 38% of patients in the placebo arm received subsequent PARP inhibitor treatment in PRIMA, versus 12% for the Zejula arm. In the HRd subgroup, the difference was even bigger, with the rates at 48% and 16%, respectively. Still, at first glance, Zejula’s overall survival performance in PRIMA appears weaker than the result from its rival Lynparza in the PAOLA-1 trial, with cross-trial caveats considered. In a descriptive analysis of overall survival in HRd-positive patients, Lynparza plus bevacizumab reduced the risk of death by 38% versus bevacizumab alone in the PAOLA-1 trial.Lynparza’s FDA approval in first-line maintenance ovarian cancer is limited to HRd patients, and the AZ/Merck drug remains the PARP class leader within its approved HRd population. As doctors are more reluctant to use PARP inhibitors in HRp patients, Zejula’s sales have been lagging far behind Lynparza’s quarterly figures.PRIMA enrolled a higher-risk patient population compared with other studies, Abdullah said, pointing to such factors as stage of disease, visible residual disease and prior use of neoadjuvant chemotherapy as evidence.GSK will communicate the latest PRIMA data with the FDA, but Abdullah declined to comment further about potential regulatory actions.Zejula continued to show a benefit in slowing disease progression or death. At five years, about 22% of patients in the Zejula arm were estimated to be alive, versus 12% for placebo. The rates in the HRd population were 35% and 16%, respectively.“We’re comforted by the long-term safety profile and data that we see through survival despite the impact of subsequent therapies,” Abdullah said. Rubraca’s combo setbackAmong the three PARP inhibitors that have an ovarian cancer indication, pharma&’s Rubraca is the smallest player by market share. The Austrian company took over the struggling drug from the bankrupt Clovis Oncology last year. Before that, Clovis had tried to plump up Rubraca’s profile by combining the drug with BMS’ PD-1 inhibitor Opdivo. That now appears to have been a bad idea.Pharma& unveiled the failure of the Rubraca-Opdivo combo as a first-line maintenance treatment for ovarian cancer in May. Now, data from the phase 3 ATHENA-COMBO trial presented at ESMO 2024 show that patients who got the cocktail performed even worse than those who received Rubraca alone.The ATHENA-COMBO trial was a complete failure no matter which patient group was examined. In the overall trial group, the combo showed a 30% increased risk of disease progression or death versus solo Rubraca, as the median PFS was 15 months for the combo and 20.2 months for Rubraca monotherapy.In patients with or without BRCA mutations, with various levels of heterozygosity, or those with PD-L1-positive tumors, the results were the same: The Rubrca-Opdivo regimen was worse.In terms of treatment-related adverse events at grade 3 or higher, the combo arm saw a higher rate of elevated liver enzymes, which suggest liver dysfunction, at 21.2%, compared with 10% for the monotherapy arm. Patients in the combo arm stayed notably shorter on their treatment, as the median exposure to Rubraca was 8.4 months among them, compared with 14.7 months in the control group.How thoroughly the ATHENA-COMBO trial failed was somewhat of a surprise. The phase 3 DUO-O trial previously showed positive tumor progression results for adding AZ’s PD-L1 inhibitor Imfinzi to first-line chemo and bevacizumab and then adding Imfinzi and Lynparza to bevacizumab in the maintenance phase. However, that study didn’t establish a clear contribution from Imfinzi, and AZ doesn't seem to have made any regulatory filing for that use.“While the negative primary results were disappointing, the findings provide further support of Rubraca monotherapy” in the first-line maintenance setting, a pharma& spokesperson said about ATHENA-COMBO in a statement to Fierce Pharma.The problem is, Rubraca as a monotherapy has yet to win an FDA approval as a first-line maintenance treatment in ovarian cancer. Amid the FDA’s previous crackdown on the PARP inhibitor class, the agency last year rejected Rubraca’s application in that first-line setting, requesting long-term overall survival analysis from the phase 3 ATHENA-MONO trial. Likely as a punishment for Clovis’ rogue decision to file the application despite the agency’s prior warning, the FDA actually elevated its request in the rejection, asking for the final overall survival analysis in any potential future refiling. The final analysis from ATHENA-MONO will happen when 70% of patients in the trial have passed away, whereas the agency had previously told Clovis that a 50% maturity threshold would have been enough.Pharma& spoke with the FDA again in May this year, and the agency maintained its stance stated in the complete response letter, the pharma& spokesperson told Fierce. As such, the company will continue the ATHENA-MONO trial and explore a future FDA regulatory path, the spokesperson added.Even as the FDA wards off Rubraca’s first-line bid, the European Commission in November approved that indication. This month, the drug just won reimbursement in France for that first-line maintenance use, the company spokesperson said.

Phase 3Clinical ResultDrug Approval

03 Sep 2024

·endpts.com

Exclusive: Duke spinout launches in hopes of prevailing with brain cancer bispecific where Amgen, Roche did not

Adaptin Bio is launching with plans to bring a bispecific T cell engager for glioblastoma, a deadly form of brain cancer, into the clinic. The company received FDA clearance to start its clinical trial, which will be run at Duke University and enroll around 25 patients. The bispecific T cell engager was developed by researchers led by John Sampson, who previously was chair of the neurosurgery department at Duke and is now dean of the University of Colorado’s School of Medicine. Duke’s work on the therapy was supported by a $5 million NIH grant, and Adaptin conducted preclinical work on the asset with funds from an undisclosed pre-seed round. Adaptin is closing its seed round this week, but declined to disclose the amount. The company is led by Michael Roberts, who previously was VP of business development at Chelsea Therapeutics, which Lundbeck acquired in 2014. The drug, called APTN-101, is designed to bring T cells to cancer cells in hopes of stoking the immune system into fighting the cancer. The therapy targets both EGFRvIII, a protein overexpressed in glioblastoma, as well as CD3, which is found on T cells. Amgen and Roche had developed EGFRvIIIxCD3 bispecific antibodies, but both stopped work on their assets. Roche announced in February it was axing its glioblastoma bispecific amid broader pipeline cuts across its portfolio . “There has been no progress for the last 20 years — zero,” said Mustafa Khasraw, a neurosurgery professor who took over the project at Duke after Sampson moved to Colorado. He noted that there are several key obstacles, ranging from the methods used to develop drugs to the challenge of getting several biopsies to the blood-brain barrier. Khasraw and others have begun testing potential therapies for brain cancers in different ways, including first testing them on biopsies before deciding whether to administer them in humans. GSK said in May it was planning a Phase 3 trial of Zejula in glioblastoma based on the results of a combined Phase 0/2 study that used that approach. A key test for Adaptin Bio will come down the line. The startup plans to combine its bispecific T cell engager with cell therapy, and take advantage of a concept called “hitchhiking,” where manipulated T cells can move past the blood-brain barrier, hopefully directing more of the T cell engagers to the brain cancer. “We have a technology that circumvents and overcomes some of the key limitations when we talk about delivering treatments to the brain, even T cells into the brain,” Roberts said. “I do think it’s the delivery aspect that really makes the difference here.” “We need to do more innovative trials — thinking outside the box and using new approaches — because all the traditional approaches have failed in this disease for at least two decades,” Khasraw said.

Phase 3Cell TherapyImmunotherapyAcquisition

100 Deals associated with Niraparib Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Niraparib Tosylate	L01XX54	DB11793

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ovarian Cancer	CH	Tesaro, Inc.	03 Oct 2018
Peritoneal Neoplasms	CH	Tesaro, Inc.	03 Oct 2018
Ovarian Epithelial Carcinoma	IS	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Ovarian Epithelial Carcinoma	NO	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Ovarian Epithelial Carcinoma	LI	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Ovarian Epithelial Carcinoma	EU	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	EU	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	IS	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	NO	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-sensitive epithelial ovarian cancer	LI	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	EU	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	LI	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	NO	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma	IS	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	NO	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	IS	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	LI	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma	EU	GlaxoSmithKline (Ireland) Ltd.	16 Nov 2017
Fallopian Tube Carcinoma	US	GlaxoSmithKline LLC	27 Mar 2017
Primary peritoneal carcinoma	US	GlaxoSmithKline LLC	27 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
BRCA Mutation Castration-Resistant Prostate Cancer	NDA/BLA	EU	GlaxoSmithKline (Ireland) Ltd.	27 Feb 2023
Platinum-Sensitive Ovarian Carcinoma	Phase 2	GB	Tesaro, Inc.	21 Jun 2013
Platinum-Sensitive Ovarian Carcinoma	Phase 2	BE	Tesaro, Inc.	21 Jun 2013
Platinum-Sensitive Ovarian Carcinoma	Phase 2	US	Tesaro, Inc.	21 Jun 2013
Platinum-Sensitive Ovarian Carcinoma	Phase 2	DK	Tesaro, Inc.	21 Jun 2013
Platinum-Sensitive Ovarian Carcinoma	Phase 2	DE	Tesaro, Inc.	21 Jun 2013
Platinum-Sensitive Ovarian Carcinoma	Phase 2	NO	Tesaro, Inc.	21 Jun 2013
Platinum-Sensitive Ovarian Carcinoma	Discovery	ES	Tesaro, Inc.	21 Jun 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05297864 (OU-SCC-PI-4G, CTgov)	Phase 2	Recurrent Glioma \| Recurrent Low Grade Astrocytoma \| Oligodendroglioma \| Recurrent Glioblastoma	15	Niraparib	vcepcvfszt(rtimdiokub) = baakupotde rhruhcmfum (iindsfhyuo, pwghnjwdjh - gsvzhpaokm) View more	-	06 Nov 2024
NCT02655016 (PRIMA \| ENGOT-OV26 \| GOG-3012, ESMO2024) Manual	Phase 3	Ovarian Cancer First line \| Maintenance homologous recombination-deficient	733	niraparib	(lcqyvakdzl) = boinaxnbzn hqdqvkmxtb (mkhskpalxg ) View more	Positive	14 Sep 2024
				Plaebo	(lcqyvakdzl) = qypeksafjv hqdqvkmxtb (mkhskpalxg ) View more
NCT03925350 (ESMO2024) Manual	Phase 2	Melanoma ARID1A/B \| ARID2 \| ATM ... View more	14	Niraparib 300 mg	(vposgcmibf) = There were no unexpected adverse events associated with niraparibe treatment gjhchijccn (ssfavsjzld )	Positive	14 Sep 2024
				Niraparib 300 mg (non-uveal melanoma)
NCT04546373 (GEICO-88R, ESMO2024) Manual	Not Applicable	Platinum-Sensitive Ovarian Carcinoma Maintenance BRCAwt	61	Niraparib	(optlxyrfru) = ysamvdyapv ctmmutrsfg (pmswdslrrc, 28.8 - NA) View more	Positive	14 Sep 2024
NCT05065021 (Re-VOLVE, ESMO2024) Manual	Phase 2	Ovarian Cancer	20	2-3 cycles of niraparib (200-300mg/OD)/ bevacizumab (7.5mg/kg/q3w), followed by personalized phase: (A) niraparib/bevacizumab/dostarlimab (500mg/q3w), (B) paclitaxel (80mg/m2 weekly)/bevacizumab/dostarlimab, or (C) continue niraparib/bevacizumab	(pogwsshddo) = kwjvwpletz jllrajvmvy (nrschmwsyb ) View more	Positive	14 Sep 2024
NCT02655016 (PRIMA \| ENGOT-OV26 \| GOG-3012, Pubmed \| Gynecol Oncol) Manual	Phase 3	Ovarian Cancer Maintenance \| First line	289	Niraparib	(ndlgrdohyo) = tadicajsmw sdqxwoiaph (axxkiaoxtl ) View more	Positive	01 Aug 2024
				Placebo	(ndlgrdohyo) = jdyhzzhhry sdqxwoiaph (axxkiaoxtl ) View more
NCT03154281 (CTgov)	Phase 1	Ovarian Cancer \| Breast Cancer	14	niraparib+Everolimus (Cohort 1)	mmffyuvjed(rszqgqkomg) = xagyswxlds skigahbehy (wohlelzjcy, pfluiuojio - zfbdtbkryi) View more	-	01 Aug 2024
				niraparib+Everolimus (Cohort 2)	mmffyuvjed(rszqgqkomg) = dqbjhmeasz skigahbehy (wohlelzjcy, gkxijseoyc - qoqnflsaxa) View more
NCT04217798 (Pubmed) Manual	Phase 2	Platinum-Resistant Ovarian Carcinoma \|	29	Niraparib + etoposide	(yvliobyosu) = pwixzdurez mwbircunjq (uuxzwhnfnw, 3.9 - 4.4) View more	Positive	29 Jul 2024
				Niraparib + etoposide (BRCA mutation)	(vjdjopifwj) = qvmvwizvwu jprpglolug (igauxrerrz )
NCT02655016 (PRIMA/ENGOT-OV26/GOG-3012, Pubmed)	Phase 3	Ovarian Cancer First line homologous recombination deficiency	487	Niraparib	(cdgibqcmta) = ngihbblsky lhstvmfpqh (atolpxojqc )	Positive	01 Jul 2024
NCT03695380 (Pubmed) Manual	Phase 1	Ovarian Cancer Second line	74	Cobimetinib 60 mg daily + Niraparib 200 mg daily	(zltsizxdwx) = pscmuwxcpi tzlaajtqnm (ofxqhdxdel, 20 - 53) View more	Positive	01 Jun 2024
				Cobimetinib 60 mg daily + Niraparib 200 mg daily + Atezolizumab 840 mg	(zltsizxdwx) = ikhqdiouov tzlaajtqnm (ofxqhdxdel, 14 - 44) View more

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