A Phase I, open-label, single-dose study designed to assess the absorption, distribution, metabolism and excretion of [14C]-RLY-4008 in healthy male participants

Start Date12 Jul 2022

Sponsor / Collaborator

Elevar Therapeutics, Inc.

NCT04526106

/ Active, not recruitingPhase 1/2

A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 4 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3) and a rollover (Part 4).

Start Date02 Sep 2020

Sponsor / Collaborator

Elevar Therapeutics, Inc.

100 Clinical Results associated with Lirafugratinib

100 Translational Medicine associated with Lirafugratinib

100 Patents (Medical) associated with Lirafugratinib

Literatures (Medical) associated with Lirafugratinib

01 Nov 2024·Clinical Cancer Research

Understanding and Overcoming Resistance to Selective FGFR Inhibitors across FGFR2-Driven Malignancies

Article

Author: Facchinetti, Francesco ; Vasseur, Damien ; Loriot, Yohann ; Smolenschi, Cristina ; Friboulet, Luc ; Hollebecque, Antoine ; André, Fabrice ; Ponce-Aix, Santiago ; Olaussen, Ken A. ; Bigot, Ludovic ; Tselikas, Lambros ; Besse, Benjamin ; Michiels, Stefan ; Brayé, Floriane ; Scoazec, Jean-Yves ; Combarel, David ; Nobre, Catline ; Italiano, Antoine ; Barbé, Rémy ; Bahleda, Rastislav

AbstractPurpose:Understanding resistance to selective FGFR inhibitors is crucial to improve the clinical outcomes of patients with FGFR2-driven malignancies.Experimental Design:We analyzed sequential ctDNA, ± whole-exome sequencing, or targeted next-generation sequencing on tissue biopsies from patients with tumors harboring activating FGFR2 alterations progressing on pan-FGFR–selective inhibitors, collected in the prospective UNLOCK program. FGFR2::BICC1 Ba/F3 and patient-derived xenograft models were used for functional studies.Results:Thirty-six patients were included. In cholangiocarcinoma, at resistance to both reversible inhibitors (e.g., pemigatinib and erdafitinib) and the irreversible inhibitor futibatinib, polyclonal FGFR2 kinase domain mutations were frequent (14/27 patients). Tumors other than cholangiocarcinoma shared the same mutated FGFR2 residues, but polyclonality was rare (1/9 patients). At resistance to reversible inhibitors, 14 residues in the FGFR2 kinase domain were mutated—after futibatinib, only the molecular brake N550 and the gatekeeper V565. Off-target alterations in PI3K/mTOR and MAPK pathways were found in 11 patients, often together with on-target mutations. At progression to a first FGFR inhibitor, 12 patients received futibatinib or lirafugratinib (irreversible inhibitors), with variable clinical outcomes depending on previous resistance mechanisms. Two patients with TSC1 or PIK3CA mutations benefited from everolimus. In cell viability assays on Ba/F3 and in pharmacologic studies on patient-derived xenografts, irreversible inhibitors retained better activity against FGFR2 kinase domain mutations, with lirafugratinib active against the recalcitrant V565L/F/Y.Conclusions:At progression to FGFR inhibitors, FGFR2-driven malignancies are characterized by high intra- and interpatient molecular heterogeneity, particularly in cholangiocarcinoma. Resistance to FGFR inhibitors can be overcome by sequential, molecularly oriented treatment strategies across FGFR2-driven tumors.

01 Apr 2024·Nature Reviews Clinical Oncology

FGFR-targeted therapeutics: clinical activity, mechanisms of resistance and new directions

Review

Author: Katoh, Masuko ; Wainberg, Zev A ; Katoh, Masaru ; Brandi, Giovanni ; Loriot, Yohann ; Tavolari, Simona

Fibroblast growth factor (FGF) signalling via FGF receptors (FGFR1-4) orchestrates fetal development and contributes to tissue and whole-body homeostasis, but can also promote tumorigenesis. Various agents, including pan-FGFR inhibitors (erdafitinib and futibatinib), FGFR1/2/3 inhibitors (infigratinib and pemigatinib), as well as a range of more-specific agents, have been developed and several have entered clinical use. Erdafitinib is approved for patients with urothelial carcinoma harbouring FGFR2/3 alterations, and futibatinib and pemigatinib are approved for patients with cholangiocarcinoma harbouring FGFR2 fusions and/or rearrangements. Clinical benefit from these agents is in part limited by hyperphosphataemia owing to off-target inhibition of FGFR1 as well as the emergence of resistance mutations in FGFR genes, activation of bypass signalling pathways, concurrent TP53 alterations and possibly epithelial-mesenchymal transition-related isoform switching. The next generation of small-molecule inhibitors, such as lirafugratinib and LOXO-435, and the FGFR2-specific antibody bemarituzumab are expected to have a reduced risk of hyperphosphataemia and the ability to overcome certain resistance mutations. In this Review, we describe the development and current clinical role of FGFR inhibitors and provide perspective on future research directions including expansion of the therapeutic indications for use of FGFR inhibitors, combination of these agents with immune-checkpoint inhibitors and the application of novel technologies, such as artificial intelligence.

06 Feb 2024·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

Discovery of lirafugratinib (RLY-4008), a highly selective irreversible small-molecule inhibitor of FGFR2

Q1 · CROSS-FIELD

Article

Author: Shaw, David E ; Mader, Mary M ; O'Hearn, Patrick J ; Maglic, Dejan ; Casaletto, Jessica B ; Bruderek, Kamil ; Hudson, Brandi M ; Valverde, Roberto ; Bergstrom, Donald A ; Zhao, Songping ; Watters, James ; Gunaydin, Hakan ; Taylor, Alexander M ; Boezio, Alessandro A ; Giordanetto, Fabrizio ; Moustakas, Demetri T ; McLean, Thomas H ; Ayaz, Pelin ; Sharon, Dina A ; Garfinkle, Sam ; Foster, Lindsey ; Wang, Yanxia ; Gerami-Moayed, Nastaran ; Schönherr, Heike ; Lescarbeau, André ; Naik, Gaauri ; Touré, B Barry ; Chen, Rongfeng ; Kurukulasuriya, Ravi

Fibroblast growth factor receptor (FGFR) kinase inhibitors have been shown to be effective in the treatment of intrahepatic cholangiocarcinoma and other advanced solid tumors harboring FGFR2 alterations, but the toxicity of these drugs frequently leads to dose reduction or interruption of treatment such that maximum efficacy cannot be achieved. The most common adverse effects are hyperphosphatemia caused by FGFR1 inhibition and diarrhea due to FGFR4 inhibition, as current therapies are not selective among the FGFRs. Designing selective inhibitors has proved difficult with conventional approaches because the orthosteric sites of FGFR family members are observed to be highly similar in X-ray structures. In this study, aided by analysis of protein dynamics, we designed a selective, covalent FGFR2 inhibitor. In a key initial step, analysis of long-timescale molecular dynamics simulations of the FGFR1 and FGFR2 kinase domains allowed us to identify differential motion in their P-loops, which are located adjacent to the orthosteric site. Using this insight, we were able to design orthosteric binders that selectively and covalently engage the P-loop of FGFR2. Our drug discovery efforts culminated in the development of lirafugratinib (RLY-4008), a covalent inhibitor of FGFR2 that shows substantial selectivity over FGFR1 (~250-fold) and FGFR4 (~5,000-fold) in vitro, causes tumor regression in multiple FGFR2 -altered human xenograft models, and was recently demonstrated to be efficacious in the clinic at doses that do not induce clinically significant hyperphosphatemia or diarrhea.

News (Medical) associated with Lirafugratinib

27 Jan 2025

·www.globenewswire.com

Elevar Therapeutics Announces the Formation and Members of Scientific Advisory Board

Scientific Advisory Board formed with internationally recognized liver and biliary tract cancer physicians to support the advancement of solid tumor pipeline programsElevar plans for major 2025 oncology regulatory milestones- March 2025 PDUFA date and launch preparation for unresectable hepatocellular carcinoma- NDA Submission for lirafugratinib in second half 2025 for FGFR2 driven cholangiocarcinoma FORT LEE, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a portfolio company of HLB Co., Ltd., today announced the formation of its Scientific Advisory Board (SAB) with internationally renowned experts in the discovery and development of next generation hepatocellular carcinoma and cholangiocarcinoma cancer therapies. “We proudly welcome our newly formed Scientific Advisory Board, a distinguished group of oncology clinicians who will play a crucial role in supporting our research and development strategy. Their individual and collective expertise will be invaluable as we strive to make a meaningful impact in the fight against cancer,” commented Chris Galloway, M.D., senior vice president of clinical development and medical affairs at Elevar. Mitesh Borad, M.D. Mitesh J. Borad, M.D., is the Getz Family Research Professor and leads the Novel Therapeutics and Modalities Program at Mayo Clinic. Dr. Borad is an internationally recognized expert for treating patients with cholangiocarcinoma and has been extensively involved in developing novel cancer therapeutic platforms that leverage genomic medicine and gene/virus therapies, with a focus on tumors of the liver, bile ducts and pancreas. He has led the clinical development of novel anti-cancer agents in more than 50 first-in-human studies, including a multi-institutional team with collaborators at Mayo Clinic and the Translational Genomics Research Institute, which led to the discovery of fibroblast growth factor 2 (FGFR2) fusions in patients with intrahepatic cholangiocarcinoma, with the first demonstration of anti-tumor activity with FGFR inhibitors in this patient population. Subsequent work led to the FDA approval of three FGFR inhibitor cancer therapies. Richard Kim, M.D. Dr. Richard Kim is a Service Chief of Medical Gastrointestinal Oncology and Senior Member in the Gastrointestinal Oncology Department at Moffitt Cancer Center and a Professor of Oncology at the University of South Florida College of Medicine. Before joining Moffitt in 2010, Dr. Kim was an associate physician in gastrointestinal malignancies at the Cleveland Clinic Taussig Cancer Center and a clinical assistant professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Cleveland, OH. Dr. Kim’s clinical and research interests focus on gastrointestinal tumors, in particular hepatobiliary and colon cancer. He is a principal investigator in multiple investigator-initiated and pharmaceutical phase I, II and III trials using immunotherapy and novel targeted agents. Daneng Li, M.D. Daneng Li, M.D. is an Associate Professor in the Department of Medical Oncology & Therapeutics Research at City of Hope, specializing in treating gastrointestinal cancers. Dr. Li currently leads the liver tumors program and is also the co-director of the Neuroendocrine Tumor Program at City of Hope. Dr. Li’s clinical and academic research is focused on the multidisciplinary approach to treatment of patients with neuroendocrine tumors (NETs). He leads several clinical trials focused on improving outcomes for patients with NETs and works closely with scientists in the development of the next generation of novel therapeutics. Rachna T Shroff, M.D., M.S. Rachna T. Shroff, MD, MS, FASCO, serves as associate director of Clinical Investigations and co-leader of the Gastrointestinal Clinical Research Team at the University of Arizona Cancer Center (UACC) and is a professor in the Department of Medicine, chief of the Division of Hematology and Oncology, medical director for the Oncology Service Line and associate dean for Clinical and Translational Research for the University of Arizona College of Medicine – Tucson. Dr. Shroff joined UACC from MD Anderson Cancer Center in Houston. She is a clinical and translational investigator focused on developing novel therapies for pancreatic and hepatobiliary cancers and has led numerous clinical trials focusing on pancreaticobiliary tumors. She was the national principal investigator for SWOG 1815, which investigated a triplet chemotherapy regimen as a potential new standard of care for biliary cancers. About Elevar Therapeutics Elevar Therapeutics, Inc., a fully owned subsidiary of HLB Group, is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for patients who have limited or inadequate therapeutic options. With expertise rooted in oncology, Elevar is focused on identifying and developing promising medicines for complex yet under-treated health conditions. Elevar’s lead proprietary drug candidate is rivoceranib. The NDA for rivoceranib in combination with camrelizumab as a therapy for advanced or metastatic hepatocellular carcinoma (HCC) is currently under review by the FDA with a PDUFA action date scheduled for March 20, 2025. On December 2, 2023, Elevar acquired worldwide rights to develop and commercialize lirafugratinib (RLY-4008), an FGFR2 inhibitor that has shown differentiated efficacy in FGFR2-driven cholangiocarcinoma (CCA) and demonstrated durable responses across multiple other types of FGFR2-altered solid tumors. An NDA submission for lirafugratinib is planned for 2025. Additional information is available at www.Elevar Therapeutics.com. About HLB Group The HLB Group is comprised of HLB Inc. (KOSDAQ:028300) and its affiliates with a diverse portfolio across biopharma, lifestyle, marine business, semiconductor and energy, united by the mission of improving all aspects of human life. Members of the HLB Group include HLB Innovation (KOSDAQ: 024850), HLB BioStep (KOSDAQ:278650), HLB Pharmaceutical (KOSDAQ:047920), HLB Life Science (KOSDAQ:067630), HLB Therapeutics (KOSDAQ:115450), HLB Panagene (KOSDAQ:046210) and HLB Global (KOSDAQ:003580). HLB Group’s overseas affiliates include Elevar Therapeutics, Immunomic Therapeutics, a nucleic acid immunotherapy platform company, and Verismo Therapeutics, a CAR T platform oncology company, and a fully owned subsidiary of HLB Innovation, both based in the United States. Contacts Media: Jeanette BressiHead, Corporate Communications jbressi@elevartherapeutics.com 609-439-3997 Investors: Wade SmithChief Financial & Business Officer wsmith@elevartherapeutics.com

Phase 1Executive ChangeImmunotherapy

09 Dec 2024

·www.globenewswire.com

Relay Therapeutics to Present Updated Clinical Data on RLY-2608 in HR+/HER2- Breast Cancer at 2024 San Antonio Breast Cancer Symposium

Company to host conference call on Wednesday, December 11, 2024 at 7am ETCAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today announced that updated clinical data for RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer will be presented at the upcoming San Antonio Breast Cancer Symposium, taking place December 10-13, 2024. Details of the RLY-2608 + fulvestrant poster presentation are as follows:Abstract Title: PS7-01: Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trialAbstract Number: SESS-2211Session: Concurrent Poster Spotlight Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinationsDate/Time: Wednesday, December 11, 8:00-9:30 a.m. ET (7:00-8:30 a.m. CT) Conference Call InformationRelay Therapeutics will host a conference call to discuss these data on Wednesday, December 11, 2024 at 7:00 a.m. ET (6:00 a.m. CT). Registration and dial-in for the conference call and webcast may be accessed through Relay Therapeutics’ website under Events in the News & Events section through the following link: https://ir.relaytx.com/news-events/events-presentations. An archived replay of the webcast will be available following the event. The poster will be available at the start of the session on the company’s website at https://relaytx.com/publications/. About RLY-2608 RLY-2608 is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers, with oncogenic mutations detected in about 14% of patients with solid tumors. RLY-2608 has the potential, if approved, to address more than 300,000 patients per year in the United States, one of the largest patient populations for a precision oncology medicine. Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo® platform enabled the discovery of RLY-2608, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of RLY-2608. RLY-2608 is currently being evaluated in a first-in-human trial designed to treat patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation. For more information on RLY-2608, please visit here. About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of complementary techniques and technologies, Relay Therapeutics aims to push the boundaries of what’s possible in drug discovery. Its Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. Relay Therapeutics’ initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit www.relaytx.com or follow us on Twitter. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Relay Therapeutics’ strategy, business plans and focus; the progress and timing of the clinical development of the programs across Relay Therapeutics’ portfolio; the expected therapeutic benefits and potential efficacy and tolerability of RLY-2608, both as a monotherapy and in combination with other agents, and its other programs, including lirafugratinib as well as the clinical data for RLY-2608; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection and the expectations regarding Relay Therapeutics’ use of capital, expenses and potential cost savings. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which Relay Therapeutics has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; the delay or pause of any current or planned clinical trials or the development of Relay Therapeutics’ drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; Relay Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contact:Megan Goulart617-322-0814mgoulart@relaytx.com Media:Dan Budwick1AB973-271-6085dan@1abmedia.com

Clinical Study

04 Dec 2024

·www.biopharmadive.com

Novavax sells Czech plant to Novo; Relay licenses out a cancer drug

Today, a brief rundown of news involving Novavax and Novo Nordisk, as well as updates from Relay Therapeutics, Takeda and Tubulis that you may have missed.Novavax has agreed to sell a manufacturing plant in Bohumil, Czech Republic, to Danish drugmaker Novo Nordisk for $200 million. The factory, which can produce recombinant protein, will be transferred to Novo along with its supporting buildings, staff and related infrastructure when the deal closes. In addition to boosting Novavaxs cash holdings, the deal will reduce the vaccine makers annual operating costs by approximately $80 million. Novo, which has been investing heavily in manufacturing to meet demand for its weight loss and diabetes therapies, is in the midst of closing another deal to acquire three Catalent facilities. Delilah AlvaradoElevar Therapeutics, a majority-owned subsidiary of Koreas HLB Co., is paying $75 million to license a medicine developed by Relay Therapeutics for a form of bile duct cancer. The upfront fee gives Elevar global development and commercialization rights to the drug, called lirafugratinib. Trial data previously suggested lirafugratinib could be more effective than existing options in treating cholangiocarcinoma with certain genetic mutations. A study meant to support an application for accelerated approval is ongoing. Ned PagliaruloRoivant Sciences reported Tuesday that a study run by one of its subsidiaries, Kinevant Sciences, failed to show a benefit for the companys antibody treatment for chronic active pulmonary sarcoidosis. As a result, further development of the drug, dubbed namilumab, in sarcoidosis will be halted. Analysts had viewed this program as high-risk, high-reward, and ascribed little value to its development. Shares in Roivant fell by nearly 3% Tuesday. Ned PagliaruloTakeda will pay $200 million to secure rights outside of China, Hong Kong and Macau to an experimental blood disease drug developed by Cambridge, Massachusetts-based Keros Therapeutics. The drug, called elritercept, is in two Phase 2 trials involving people with myelodysplastic syndromes or myelofibrosis. A Phase 3 study is set to begin soon, according to the companies. The addition of elritercept further bolsters our oncology pipeline and introduces a potential future growth driver for Takeda, said Teresa Bitetti, head of Takedas oncology business unit, in a Tuesday statement. Ned PagliaruloAntibody-drug conjugate maker Tubulis announced Tuesday it has struck a deal with Gilead Sciences to find new cancer medicines. Under terms of the collaboration, Gilead paid the German biotech $20 million upfront in exchange for access to its technology and an option to license a program for an additional $30 million fee. If successful, Tubulis stands to gain as much as $415 million in development and commercialization milestone payments, as well as royalties. Gwendolyn Wu '

VaccineLicense out/inPhase 3Phase 2

100 Deals associated with Lirafugratinib

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	United Kingdom	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Hong Kong	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	France	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Italy	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Singapore	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	United States	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Taiwan Province	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Germany	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Spain	Elevar Therapeutics, Inc.	02 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 2	Sweden	Elevar Therapeutics, Inc.	02 Sep 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04526106 (REFOCUS, Corporate Publications) Manual	Phase 1/2	Solid tumor FGFR2 fusions \| FGFR2 amplifications \| FGFR2 mutations	84	Lirafugratinib (patients with FGFR2 fusions)	(xuyoryyyrt) = nvaiuddskt jkffhyfgll (agivrwxxxd )	Positive	12 Oct 2023
				Lirafugratinib (patients with breast cancer across all FGFR2 alterations, 10 of whom had HR+/HER2- breast cancer)	(xuyoryyyrt) = ytnunzllwf jkffhyfgll (agivrwxxxd )
NCT04526106 (ReFocus, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Solid tumor \| Bile Duct Neoplasms	75	RLY-4008 (FGFRi-naïve CCA f/r)	(kcuetcdzyc) = 70 mg QD huswbkomqf (hmzmxdrcpr ) View more	Positive	26 May 2023
				RLY-4008 (Prior-FGFRi CCA f/r)
AACR2023	Phase 1/2	-	-	RLY-4008 (fasted)	(fjjuydwoza) = lpuxyzvsvf gyhivgwopf (gtcpwlekrv )	-	04 Apr 2023
				RLY-4008 with food	(fjjuydwoza) = udqdplifxn gyhivgwopf (gtcpwlekrv )
NCT04526106 (ReFocus, ESMO_ASIA2022)	Phase 1/2	FGFR2 fusion or rearranged Cholangiocarcinoma	38	RLY-4008	(zmpwmcjpbg) = majority of responses ongoing nsiegcvsxz (zufzjzmhdy )	-	04 Dec 2022
NCT04526106 (ReFocus, ESMO2022) Manual	Phase 1/2	FGFR2 fusion or rearranged Cholangiocarcinoma First line \|	195	RLY-4008 20-200 mg QD or BID (RP2D (70 mg QD))	(sxemjekwkz) = eedaruqsiy imyipnifbd (gmsiaqowuu, 56.6 - 96.2) View more	Positive	11 Sep 2022
				RLY-4008 20-200 mg QD or BID (All dose levels)	(sxemjekwkz) = kdbgwtsorr imyipnifbd (gmsiaqowuu, 40.8 - 73.7) View more
NCT04526106 (ReFocus, AACR2021) Manual	Phase 1/2	Solid tumor \| FGFR2 fusion or rearranged Cholangiocarcinoma FGFR2 Mutation	45	RLY-4008	(jnigyocote) = AEs occurring in >20% of pts include stomatitis (49%), palmar-plantar erythrodysesthesia (PPE, 38%), dry mouth (29%), and nail toxicities (22%), majority of which were ≤Gr 2. abypipstxv (amgccvrlft ) View more	Positive	01 Dec 2021
				RLY-4008 (FGFRi-naïve, FGFR2-fusion+ CCA)

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