ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), TrkA antagonists(Nerve growth factor receptor Trk-A antagonists), TrkB inhibitors(Neurotrophic tyrosine kinase receptor type 2 inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesImmune System Diseases+ [3]

Active Indication

NTRK fusion-positive solid tumorsReactive oxygen species 1 positive non-small cell lung cancerHR Positive/HER2 Negative Lobular Carcinoma+ [6]

Inactive Indication

KRAS G12D mutation Solid TumorsKRAS mutation-related tumorsLocally Advanced Malignant Solid Neoplasm

Originator Organization

Turning Point Therapeutics, Inc.

Active Organization

Zai Lab (Shanghai) Co., Ltd.

Turning Point Therapeutics, Inc.

Bristol Myers Squibb Co.

+ [3]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (15 Nov 2023),

Reactive oxygen species 1 positive non-small cell lung cancer

RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN)

Structure/Sequence

Molecular FormulaC18H18FN5O2

InChIKeyFIKPXCOQUIZNHB-UHFFFAOYSA-N

CAS Registry1802220-02-5

Clinical Trials associated with Repotrectinib

NCT06315010

/ Not yet recruitingPhase 2

A Phase II Study Assessing Safety and Efficacy of REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis (REPOSE Study)

REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene.

Start Date01 Feb 2025

Sponsor / Collaborator

Medica Scientia Innovation Research SL

[+1]

NCT05828303

/ Not yet recruitingPhase 1

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements

This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.

Start Date15 Nov 2024

Sponsor / Collaborator

Turning Point Therapeutics, Inc.

CTRI/2024/10/075224

/ Not yet recruitingPhase 3

Randomized, Open-label, Multicenter,Phase 3 Trial of Repotrectinib VersusCrizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) - NIL

Start Date01 Nov 2024

Sponsor / Collaborator

Bristol-Myers Squibb India Pvt Ltd.

100 Clinical Results associated with Repotrectinib

100 Translational Medicine associated with Repotrectinib

100 Patents (Medical) associated with Repotrectinib

Literatures (Medical) associated with Repotrectinib

01 Jan 2025·Med

If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide

Review

Author: Adashek, Jacob J ; Munoz, Javier L ; Kurzrock, Razelle

Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAF^V600E mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms. The genomically driven tissue-agnostic approach has a strong biological rationale (cancer is a disease of the genome), yields remarkably high response rates, and provides drug access to patients with an unmet need (rare/ultra-rare malignancies). Despite the solid tumor focus, both solid and hematologic cancers can harbor identical driver molecular abnormalities and respond to cognate therapies. For example, BRAF^V600E and IDH1/2 mutations; ALK, FGFR, and NTRK fusions; PD-L1 amplification; and CD70 antigens are druggable in both solid and blood malignancies by gene-/immune-targeted therapies/chimeric antigen receptor T cells. Future biomarker-based tissue-agnostic basket studies/approvals should bridge the great divide and include both solid and hematologic cancers.

20 Dec 2024·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

The promising impact of Bemcentinib and Repotrectinib on sleep impairment in Alzheimer’s disease

Article

Author: Ramezani, Fatemeh ; Ariaei, Armin

Alzheimer's disease (AD), the most prevalent neurodegenerative disease, demands effective medication to alleviate symptoms. This study focused on sleep impairment as an overt clinical symptom and tauopathy as a prominent molecular symptom of this disease. Multiple compounds from three biomolecule libraries (719 compounds; ChemDiv:366 - ChEMBL:180 - PubChem:173) were evaluated for potential binding affinity and safety using AutoDock Vina and pkCSM, respectively, resulting in the selection of four candidate compounds (Lestaurtinib, Repotrectinib, Bemcentinib, and Zotiraciclib). Due to the similarity of Repotrectinib and Bemcentinib binding sites to ATP, 300 ns Martini 3 coarse-grained molecular dynamics (MD) was performed on these two molecules and ATP by NAMD. The stability of tau protein in the presence of drugs was assessed using a 200 ns Martini 3 MD simulation. Binding site analysis discloses Bemcentinib and Repotrectinib as two inhibitors occupying most amino acids in binding with ATP. The RMSD and RMS average correlation results revealed protein containing Bemcentinib and Repotrectinib to have a more stable state compared to ATP in the first 220 ns simulation. There was only a single detachment of Bemcentinib, while Repotrictinib detached twice at the end of the simulation. Eventually, adding Bemcentinib and Repotrectinib to the enzyme-tau complex significantly increased the number of tau detachments during the 200 ns simulation. We report Bemcentinib and Repotrectinib, formerly prescribed for cancer, as potential inhibitors of the CK1 δ. Besides their high binding affinity compared to ATP, they can inhibit all ATP-binding sites and alter the tau binding stability.Communicated by Ramaswamy H. Sarma.

01 Dec 2024·International Journal of Clinical Oncology

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of sacituzumab govitecan for breast cancer, fruquintinib for colorectal cancer, amivantamab for lung cancer, repotrectinib for lung cancer, tasurgratinib for biliary tract cancer, enfortumab vedotin plus pembrolizumab for urothelial cancer, and dabrafenib plus trametinib for glioma in Japan

Author: Matsumura, Noriomi ; Mandai, Masaki

102

News (Medical) associated with Repotrectinib

07 Jan 2025

·endpts.com

Exclusive: Avenzo picks up another ADC, this time with multi-partnered DualityBio

Avenzo Therapeutics, a well-funded biotech that has in-licensed treatment candidates from Chinese drug developers, has forged its third deal since reassembling much of the Turning Point Therapeutics crew. Athena Countouriotis’ San Diego biotech is tapping en vogue startup DualityBio for access to a bispecific antibody-drug conjugate in a space that attracted Bristol Myers Squibb’s interest in 2023. Avenzo is dishing out $50 million upfront for the ex-China rights to DualityBio’s preclinical EGFRxHER3 bispecific, the company told Endpoints News exclusively. The candidate is codenamed DB-1418 and will also be known as AVZO-1418 going forward. As ADCs have become one of the pharmaceutical industry’s oncology drug modalities of choice in recent years — leading to many buyouts, megaround financings and treatment approvals — drugmakers have turned to bispecific versions of the decades-old space to bring it into the future. Bristol Myers had paid $800 million upfront for SystImmune’s bispecific going after the same targets in 2023. The key difference: SystImmune had already entered Phase 1 testing by the time it signed that deal. Countouriotis, Avenzo’s founder and CEO, told Endpoints that her company expects AVZO-1418/DB-1418 to enter a human trial this year in the US and potentially Australia. In an interview, she said Avenzo could explore the ADC in lung, breast and bladder cancer. Duality has described DB-1418 as having a “1+1” format that could lead to better binding to tumor cells, sparing more healthy cells in the process. “As it relates to EGFRxHER3, there’s obviously one that dictated a very big number upfront last year with a partnership with BMS, and we saw holes in that asset right away as it relates specifically to the safety profile, as well as some of the preclinical data that we have with the Duality asset,” Countouriotis said. “We think it can be best in class. It’s not far behind. There’s nothing approved.” The Avenzo team is quite familiar with BMS. The New York pharma acquired Countouriotis’ Turning Point for $4.1 billion in 2022 and subsequently got FDA approval for its lung cancer drug Augtyro . Many of those Turning Point employees have reunited at Avenzo. For its part, DualityBio has quickly become one of the leading ADC partners. Within five years of its inception, the biotech discovered about a dozen ADCs, according to its August application to list on the Hong Kong Stock Exchange . And it has inked partnerships with BeiGene , Adcendo , BioNTech and, last month, GSK . “In a time where you’re seeing a lot of deals coming out of China, Duality is a company that has aspirations to go public on the Hong Kong Stock Exchange, but also that has shown the validity of their team and their platform with the multiple deals that they’ve done before,” Countouriotis said. “For us to slide in after BioNTech, BeiGene and GSK — which are obviously much bigger than Avenzo — I’m pretty excited that they chose us as a partner.” DualityBio stands to gain billions of dollars from its tie-ups. With regard to the new Avenzo collaboration, it could receive up to about $1.15 billion in biobucks. Avenzo has promised a total of about $3 billion in milestone payments across its three deals. It’ll likely be multiple years before it has to deliver significant chunks of those biobucks, though, and the company has raised ample capital to get clinical data on its assets. Avenzo has 17 investors and has raised about $386 million to date. The biotech’s DualityBio collaboration follows its recent option to snag VelaVigo ’s Nectin-4/TROP2 bispecific ADC, and a January 2024 deal for Allorion Therapeutics ’ CDK2 inhibitor. The company had been interested in DLL3-targeting ADCs at one point, but it was “very crowded, everyone has one and everyone’s in Phase 1,” Countouriotis said. Roche and Ideaya Biosciences both struck DLL3 pacts in the ADC space in recent weeks. With three deals in tow, Avenzo is likely all set on its pipeline for now. It has about 40 employees and will nearly double in headcount this year, Countouriotis said. The workforce growth will focus on clinical development and financial expertise as Avenzo ramps up trials and gets closer to an IPO, she said.

ADCPhase 1Drug Approval

28 Nov 2024

·www.businesswire.com

Zai Lab Announces the Inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC and Other Updates in China’s National Reimbursement Drug List

SHANGHAI & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2024 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications: AUGTYRO ® (repotrectinib) is included in the NRDL for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC); NUZYRA ® (omadacycline) is renewed for its intravenous (IV) formulation for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI); and QINLOCK ® (ripretinib) is renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. “The NRDL inclusion of AUGTYRO significantly expands access to patients living with ROS1 + NSCLC in China to a new treatment option with promising durability. We look forward to launching AUGTYRO by the end of 2024,” said Andrew Zhu, Chief Commercial Officer of Zai Lab. “The addition of AUGTYRO, as well as the renewals of NUZYRA and QINLOCK, further support patient access to these important medications throughout China at more affordable treatment costs for patients and their families.” “A key part of Zai Lab’s mission is to bring innovative medicines to patients with significant unmet medical needs,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “We are pleased that we now have six products included in the NRDL, and we will continue our efforts to broaden patient access to our innovative treatments across China. We look forward to continuing to work with the NHSA to improve affordability and accessibility for differentiated innovative treatments in China, with the goal of improving patient lives.” About ROS1 + NSCLC in China Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 1,060,600 new cases and 733,300 cases of deaths from lung cancer in China in 2022. 1 NSCLC accounts for approximately 85% of lung cancer, and approximately 70% of NSCLC is locally advanced or metastatic at initial diagnosis. In China, ROS1 rearrangements occur in approximately 2% of patients with advanced NSCLC. 2 1 Bingfeng Han, et al. Cancer incidence and mortality in China, 2022. 2 Zhang, et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer, Thoracic Cancer January 2019. About AUGTYRO AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI) that targets ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 or NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of drugs to their target. Ultimately, this leads to shortened duration of response and tumor progression. AUGTYRO is the first next-generation TKI that targets ROS1 oncogenic fusions in NSCLC and provides improved durability of benefit, including in metastases to the brain. In November 2023, AUGTYRO was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic ROS1 -positive NSCLC. In May 2024, AUGTYRO was approved by China’s National Medical Products Administration (NMPA) for the same indications. Additionally, in August 2023, the NMPA granted AUGTYRO Breakthrough Therapy Designation for the treatment of patients with advanced solid tumors harboring a NTRK gene fusion. Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively). Zai Lab expects to commercially launch AUGTYRO in mainland China by the end of 2024. About CABP and ABSSSI in China CABP is the most common type of pneumonia that is acquired outside of the hospital. It is one of the most common infectious diseases and is a significant cause of mortality and morbidity worldwide. ABSSSI are bacterial infections of skin and associated soft tissues, such as loose connective tissue and mucous membranes. ABSSSI are common and encompass a variety of disease presentations and degrees of severity. In 2020, the estimated incidence of CABP in mainland China was approximately 10 million patients 3 , and in 2015, the estimated incidence of ABSSSI was 2.8 million patients 4 . There are significant unmet needs for broad-spectrum antibiotics addressing multi-drug resistance infections with a favorable safety profile. 3 Incidence of community-acquired pneumonia in urban China: A national population-based study, 2020. 4 2015 estimates, Zai Lab analysis. About NUZYRA NUZYRA (omadacycline), a novel tetracycline-class antibacterial with both oral and IV formulations, is active across a broad spectrum of bacterial infections, such as those caused by Gram-positive, Gram-negative, atypical, and many other pathogens. The NMPA approved NUZYRA as a Category 1 innovative drug for both oral and IV formulations for the treatment of CABP and ABSSSI in adult patients, and Zai Lab launched NUZYRA in mainland China for these indications in December 2021. It was included in the NRDL for the treatment of adult patients with CABP and ABSSSI in January 2023 for its IV formulation and in January 2024 for its oral formulation. Zai Lab has an exclusive license from Paratek Pharmaceuticals, Inc. (acquired by Novo Holdings A/S) to develop, manufacture, and commercialize NUZYRA in Greater China. About GIST in China It is estimated that approximately 30,000 GIST patients are newly diagnosed each year in China. Treatment of GIST remains an important unmet medical need in China as many GIST patients, who initially respond to traditional TKIs, ultimately develop tumor progression due to secondary mutations. About QINLOCK QINLOCK (ripretinib) is an orally administered switch-control TKI that inhibits KIT and PDGFRA kinases, including wild-type and forms with multiple primary and secondary mutations, by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. The NMPA approved QINLOCK in March 2021 for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib, and Zai Lab launched QINLOCK in mainland China for this indication in 2021. It was included in the NRDL in January 2023 for the treatment for GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. Zai Lab has an exclusive license agreement with Deciphera Pharmaceuticals, Inc. (a member of ONO Pharmaceutical) for the development and commercialization of QINLOCK in Greater China. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global . Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements relating to the benefits and potential of AUGTYRO (repotrectinib), NUZYRA (omadacycline), and QINLOCK (ripretinib) and the treatment of ROS1 + NSCLC, CAPB, ABSSSI and GIST in Greater China. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov .

Drug ApprovalLicense out/inBreakthrough TherapyPriority ReviewNDA

15 Nov 2024

·endpts.com

European drug regulators offer wave of positive recommendations following Leqembi reversal

The European Medicines Agency’s human medicines committee handed down a slew of positive recommendations for drugs on Friday, including Merck’s blockbuster cancer drug Keytruda and InflaRx’s monoclonal antibody Gohibic for Covid-19. The committee recommended label expansions for 11 drugs, including the Keytruda-pemetrexed-platinum chemotherapy combination for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma, and Bristol Meyers Squibb’s Opdivo-Yervoy combination for the first-line treatment of a type of unresectable or metastatic colorectal cancer. Eight new medicines were recommended for approval, including a marketing authorization under exceptional circumstances for Gohibic for the treatment of SARS‑CoV2‑induced acute respiratory distress syndrome. The FDA granted it an emergency use authorization last year. InflaRx noted in a statement that the exceptional circumstances recommendation means that the benefit-risk assessment of the drug is positive — but “due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use.” InflaRx added that approval in the EU is expected early next year and that it’s considering potential partnerships for commercial distribution. Bristol Myers’ oral tyrosine kinase inhibitor, Augtyro, won a conditional marketing authorization recommendation for advanced solid tumors and locally advanced or metastatic non-small cell lung cancer. Four biosimilars were also recommended, including: Formycon’s Baiama and Klinge Biopharma’s Ahzantive as biosimilars to Eylea for several forms of macular degeneration and other eye diseases; Samsung Bioepis’ denosumab biosimilars Obodence for osteoporosis and bone loss, and Xbryk for the prevention of issues like fractures in adults with bone tumors. Samsung Bioepis touted the recommendations, noting that if the European Commission authorizes the drugs, they would be Samsung Bioepis’ first endocrinology biosimilars approved in Europe. The committee also rejected two drugs: Legacy Healthcare’s Cinainu for the treatment of alopecia areata, a disease that causes hair loss, and Orphelia Pharma’s Kizfizo for the treatment of neuroblastoma. These decisions come on the heels of the committee reversing course and deciding in favor of Eisai and Biogen’s Alzheimer’s treatment Leqembi on Thursday for the treatment of a subset of early-stage Alzheimer’s patients who have one or no copies of a form of a gene called APOE4. That gene can make it more likely that a patient experiences brain imaging abnormalities known as ARIA, an adverse event linked with Leqembi. The committee originally recommended against Leqembi in a broader Alzheimer’s population over the summer.

Drug ApprovalAccelerated Approval

100 Deals associated with Repotrectinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11454	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
NTRK fusion-positive solid tumors	US	Bristol Myers Squibb Co.	13 Jun 2024
Reactive oxygen species 1 positive non-small cell lung cancer	US	Bristol Myers Squibb Co.	15 Nov 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HR Positive/HER2 Negative Lobular Carcinoma	Phase 2	US	The University of Texas MD Anderson Cancer Center	08 Aug 2024
KRAS G12D mutation Solid Tumors	Phase 2	US	Turning Point Therapeutics, Inc.	23 Sep 2021
KRAS mutation-related tumors	Phase 2	US	Turning Point Therapeutics, Inc.	23 Sep 2021
NTRK fusion-positive Non-small Cell Lung Cancer	Phase 2	CN	Turning Point Therapeutics, Inc.	10 May 2021
NTRK fusion-positive Non-small Cell Lung Cancer	Phase 2	CN	Zai Lab (Shanghai) Co., Ltd.	10 May 2021
NTRK fusion-positive Non-small Cell Lung Cancer	Phase 2	HK	Turning Point Therapeutics, Inc.	10 May 2021
NTRK fusion-positive Non-small Cell Lung Cancer	Phase 2	HK	Zai Lab (Shanghai) Co., Ltd.	10 May 2021
NTRK fusion-positive Non-small Cell Lung Cancer	Phase 2	TW	Turning Point Therapeutics, Inc.	10 May 2021
NTRK fusion-positive Non-small Cell Lung Cancer	Phase 2	TW	Zai Lab (Shanghai) Co., Ltd.	10 May 2021
Anaplastic Large-Cell Lymphoma	Phase 2	US	Turning Point Therapeutics, Inc.	12 Mar 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03093116 (TRIDENT-1, FDA_CDER) Manual	Phase 1/2	Reactive oxygen species 1 positive non-small cell lung cancer ROS1 Positive	127	AUGTYRO (ROS1 Inhibitor Naïve Patients)	wzepsgcufl(wzsvsejbhq) = rxalaophcc qgfkujbmnj (syjznlrydw, 68 - 88) View more	Positive	13 Jun 2024
				AUGTYRO (ROS1 Inhibitor Pretreated Patients)	wzepsgcufl(wzsvsejbhq) = jqfhuogyze qgfkujbmnj (syjznlrydw, 25 - 52) View more
NCT03093116 (TRIDENT-1, FDA_CDER) Manual	Phase 1/2	NTRK fusion-positive solid tumors NTRK gene fusion-positive	88	AUGTYRO (TKI-Naïve Patients)	sschrurinl(yknxyiatxw) = uoramfpwdt jmdlcsyyib (fsevcynwfe, 41 - 73) View more	Positive	13 Jun 2024
				AUGTYRO (TKI-Pretreated Patients)	sschrurinl(yknxyiatxw) = fsapeeemql jmdlcsyyib (fsevcynwfe, 35 - 65) View more
NCT03093116 (TRIDENT-1, ASCO2024)	Phase 1/2	Metastatic Solid Tumor \| Advanced Malignant Solid Neoplasm ROS1+	565	Repotrectinib 160 mg QD for 14 days, then 160 mg BID	bwqxdmnodn(enmaprsfgu) = gphlflqszn ymtzqezmbu (fyajlfbwpj, 68 - 88) View more	Positive	24 May 2024
NCT05071183 (CTgov)	Phase 1/2	KRAS G12D mutation Solid Tumors \| KRAS mutation-related tumors	9	Trametinib+Repotrectinib (Dose Level 1)	rvotxycrbv(vyqiqwjlog) = kzdcxfukss fpzqfhepdb (ajcwwjgdrr, ezcrtjkkhi - nmnaxxyznk) View more	-	02 Apr 2024
				Trametinib+Repotrectinib (Dose Level 2)	rvotxycrbv(vyqiqwjlog) = cichbydpdq fpzqfhepdb (ajcwwjgdrr, fwmbfrwchy - jalwlmcokl) View more
ESMO_ELCC2024	Phase 1/2	Reactive oxygen species 1 positive non-small cell lung cancer TKI-naïve	71	Repotrectinib	xaffjicvlx(ciweukuahz): OR = 1.53 (95% CI, 0.64 - 3.67) View more	Positive	22 Mar 2024
				Entrectinib
NCT03093116 (TRIDENT-1, NEWS) Manual	Phase 1/2	NTRK fusion-positive solid tumors \| Reactive oxygen species 1 positive non-small cell lung cancer ROS1 Positive \| ROR1 Positive	-	Repotrectinib (ROS1+ TKI-naïve NSCLC)	exjhesjtri(ljlssigfpd) = eexihrvfdq arcmdgfvvo (rvliomywof, 27.4 - NR) View more	Positive	08 Jan 2024
				Repotrectinib (ROS1+ TKI-pretreated NSCLC with 1 prior TKI and 1 prior chemotherapy)	tsbboucnqj(fijlrsvewq) = yblebmpzch whvfinqhtf (smjpipvoqb ) View more
NCT03093116 (TRIDENT-1, ESMO_ASIA2023)	Phase 1/2	Reactive oxygen species 1 positive non-small cell lung cancer ROS1+	71	Repotrectinib	ugjwansdzf(vahtkhjxzz) = wmoupohzrt hklbrsevsq (zraeolpyod, 74 - 96)	Positive	02 Dec 2023
				Repotrectinib	ugjwansdzf(vahtkhjxzz) = aseappbboy hklbrsevsq (zraeolpyod, 16 - 57)
NCT03093116 (TRIDENT-1, FDA) Manual	Phase 1/2	Reactive oxygen species 1 positive non-small cell lung cancer ROS1 Positive	264	AUGTYRO	qqpwpkrrot(burcgnbvdz) = zpxbombtms ktuanctoat (behtchhbrx )	Positive	15 Nov 2023
				AUGTYRO (ROS1 Inhibitor Naïve Patient)	dadixxorwk(xvlziiumnf) = jxztammmce knopglogju (durzpfwemw, 68 - 88) View more
NCT03093116 (TRIDENT-1, ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	NTRK fusion-positive solid tumors NTRK fusion	426	Repotrectinib 160 mg (TKI-naïve cohort)	haoefjowak(dzgupdobji) = moeyatkprv eizjusdvis (rtmbmovjjz, 41–73) View more	Positive	23 Oct 2023
				Repotrectinib 160 mg (TKI-pretreated cohort)	haoefjowak(dzgupdobji) = rqchkqswbe eizjusdvis (rtmbmovjjz, 35–65) View more
NCT03093116 (TRIDENT-1, WCLC2023) Manual	Phase 1/2	Reactive oxygen species 1 positive non-small cell lung cancer ROS1 Positive	426	Repotrectinib	pofihcgewz(zclznjyszt) = qusnefmjui bzvpyycgel (gmnhbjzrvc ) View more	Positive	10 Sep 2023
				Repotrectinib (TKI-naïve cohort)	myrhmhsute(qvyyptalfc) = tysyzfhlah wgemydtcet (jmjobwqzrh, 68 - 88) View more

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