RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)

Structure/Sequence

Molecular FormulaC21H19FN6O2

InChIKeyIIXWYSCJSQVBQM-LLVKDONJSA-N

CAS Registry1454846-35-5

Clinical Trials associated with Lorlatinib

CTIS2026-525268-16-00

/ Not yet recruitingPhase 2/3IIT

DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:” “A multi-arms prospective, randomized phase II study to evaluate the best sequential therapeutic strategis in patients with metastatic non-small cell lung cancer harboring targetable genomic driver alterations”

Start Date30 Sep 2026

Sponsor / Collaborator-

ChiCTR2600131220

/ SuspendedPhase 2IIT

Lorlatinib Combined with Sacituzumab Tirumotecan Based on Peripheral Blood ctDNA as First‑Line Treatment for Patients with ALK Fusion‑Positive Locally Advanced or Metastatic Non‑Small Cell Lung Cancer: A prospective, open‑label, multicenter study

Start Date01 Sep 2026

Sponsor / Collaborator-

NCT07750704

/ Not yet recruitingPhase 2IIT

Lorlatinib Combined With Sacituzumab Tirumotecan Based on Peripheral Blood ctDNA as First-Line Treatment for Patients With ALK Fusion-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Open-Label, Multicenter Study

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of lorlatinib plus sacituzumab tirumotecan based on peripheral blood ctDNA as first-line treatment for ALK fusion NSCLC.

Start Date01 Sep 2026

Sponsor / Collaborator-

100 Clinical Results associated with Lorlatinib

100 Translational Medicine associated with Lorlatinib

100 Patents (Medical) associated with Lorlatinib

902

Literatures (Medical) associated with Lorlatinib

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of lorlatinib as first-line treatment for anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer in Italy

Article

Author: Pasello, Giulia ; Novelli, Giuseppe ; Rumi, Filippo ; Di Virgilio, Roberto ; Bearz, Alessandra ; Basile, Michele ; Di Brino, Eugenio ; Valentini, Ilaria

BACKGROUND:

Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) with high central nervous system penetration and activity against resistance mutations. Although its clinical efficacy as first-line treatment for ALK-positive advanced non-small cell lung cancer (NSCLC) has been demonstrated, its economic value within the Italian healthcare system remains to be fully established. This study evaluated the cost-effectiveness of lorlatinib compared with alectinib as first-line therapy in Italy.

METHODS:

A partitioned survival model with three health states (progression-free, progressed disease, and death) was developed from the Italian National Health Service and societal perspectives over a 30-year time horizon. Clinical efficacy inputs were derived from the CROWN trial and indirect treatment comparisons using network meta-analysis. Costs (2026 euros) included drug acquisition, subsequent treatments, healthcare resource use, adverse events, end-of-life care, and societal costs. Health outcomes were expressed as life-years (LYs) and quality-adjusted life-years (QALYs). Deterministic, probabilistic, and scenario analyses were conducted to assess uncertainty.

RESULTS:

In the base case, lorlatinib was dominant over alectinib, providing higher benefits (+2.01 LYs; +1.66 QALYs) at lower costs (-€19,210 per patient). This finding was robust across pricing scenarios. Probabilistic sensitivity analysis showed an almost 98,40% probability of cost-effectiveness at Italian willingness-to-pay thresholds.

CONCLUSIONS:

From both NHS and societal perspectives, lorlatinib represents a cost-saving and clinically superior first-line treatment option compared with alectinib for patients with ALK-positive advanced NSCLC in Italy.

31 Dec 2026·Lung Cancer Management

Clinical characteristics of ALK-positive NSCLC patients treated with sequential ALK-TKI therapies in a single-centre

Article

Author: Yoshimura, Saiki ; Fujita, Kohei ; Yamamoto, Yuki ; Imakita, Takuma ; Fujimoto, Naoki ; Tanizawa, Kiminobu ; Ito, Takanori ; Oi, Issei ; Toyama, Shogo ; Kanai, Osamu

INTRODUCTION:

Although sequential treatment with ALK-TKIs for ALK-positive lung cancer is commonly practiced in clinical settings, there are few reports on the actual treatment choices, efficacy and safety.

METHODS:

This retrospective study evaluated the treatment sequence, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) for the patients who received two or more ALK-TKIs.

RESULTS:

Eleven patients were included in the study. The median age was 59 years, and five patients (45.5%) were female. The number of ALK-TKIs administered was two in five patients, three in five patients, and four in one patient. The drugs used were Alectinib in 10 patients, Lorlatinib in eight, Brigatinib in six, Ceritinib in three, and Crizotinib in two. Six patients (54.5%) had a history of treatment with cytotoxic chemotherapy in addition to ALK-TKIs. The most common first-line drug was Alectinib, followed by Brigatinib and Crizotinib. The median PFS for each treatment line was 23 months for the first line, 17 months for the second, 14 months for the third, and 5 months for the fourth. The median OS from 1^st ALK-TKI was 58 months. Discontinuation of ALK-TKI due to adverse events occurred in six of the total treatment cases, and five of these (83.3%) were attributed to Brigatinib.

CONCLUSION:

Sequential treatment with different types of ALK-TKIs demonstrated a certain degree of efficacy. However, the incidence of discontinuation due to adverse events was higher for Brigatinib than for other ALK-TKIs.

31 Dec 2026·Lung Cancer Management

Cost of managing brain metastases in ALK-positive advanced NSCLC patients receiving first-line ALK TKIs in China

Article

Author: Zhu, Fanfan ; Li, Hongchao ; Xue, Jing ; Le, Hannah ; Duan, Jia ; Hu, Bingqi ; Li, Dingsiman ; Rifi, Nada ; Dong, Peng ; Luan, Luan

AIM:

To estimate brain metastases (BM) management costs in Chinese ALK+ advanced non-small-cell lung cancer (NSCLC) patients receiving first-line (1 L) ALK tyrosine kinase inhibitors (TKIs).

METHODS:

A survey of 105 clinical experts across 23 Chinese regions evaluated healthcare resource utilization (HCRU). Total annual costs with TKIs were calculated by weighting the management costs of patients with and without BM using the cumulative incidence rate (CIR) of BM from ALK-TKI clinical trials.

RESULTS:

First-year management cost averaged ¥24,974 per-patient without BM versus ¥89,859 per-patient with BM, saving ¥64,885. Subsequent years saved ¥33,231. Applying 12-month CIR of BM, the annual costs per-patient were ¥26,791 for 1 L lorlatinib versus ¥46,516 for crizotinib in the intention-to-treat (ITT) population. Subgroup analysis showed annual costs of ¥25,623 per-patient with lorlatinib in those without BM and ¥29,775 in those with BM. Alectinib's and brigatinib's costs were ¥31,073 and ¥32,760 respectively, using the 12-month CIR of BM. Lorlatinib's cost savings increased progressively over 1-4 years. Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials.

CONCLUSION:

Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients.

News (Medical) associated with Lorlatinib

20 Oct 2026

·www.biospace.com

Guardant Health Highlights Broad Liquid Biopsy Research Portfolio at ESMO Congress 2026

Research reinforces the significance of genomic and epigenomic profiling approaches to characterize tumor types, identify biomarkers, and support risk stratification Presentations reflect Guardant’s strong biopharma and academic collaborations, along with public-private partnerships in Europe PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the company and its research collaborators will present 25 abstracts — including five rapid oral presentations—demonstrating advances in methylation-based circulating tumor DNA (ctDNA) monitoring and liquid biopsy technology across lung, colorectal, and gastric cancers at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23-27 in Madrid, Spain. The studies span Guardant's cancer portfolio, including tissue-free minimal residual disease (MRD) surveillance, treatment response, and resistance research. Significant studies were conducted independently by industry collaborators, academic institutions, and Guardant’s public-private partners using the company’s technologies and/or real-world data, underscoring the wide adoption of its platform across the research community. “At ESMO, we will showcase how InfinityAI is advancing our portfolio, strengthening the clinical relevance of our data, and delivering value to patients, healthcare professionals, and biopharma partners,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We look forward to presenting new findings and connecting with the oncology community to discuss how Guardant’s solutions can advance cancer care globally.” Key data that will be presented include: Rapid Oral 283RO : Assessing bemarituzumab in patients with advanced gastric and gastroesophageal junction cancer by fibroblast growth factor receptor 2 (FGFR2) amplification status in the FORTITUDE study, which suggests that FGFR2 amplification may identify a more treatment-sensitive subgroup. Friday, Oct. 23, 2026, Session: 4:15-5:45 p.m., Presentation: 5:19-5:24 p.m., Location: Almeria Auditorium - Hall 9 Rapid Oral LBA73 : Evaluating ctDNA-guided treatment intensification in untreated advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) to identify patients who may benefit from intensified first-line therapy in the PACE-LUNG study—a multicenter, Phase II trial of additional chemotherapy for patients with persistent EGFR-mutant ctDNA in plasma at Week 3 after starting first-line osimertinib. Saturday, October 24, 2026, Session: 8:30-10 a.m., Presentation: 8:30-8:35 a.m., Location: Almeria Auditorium - Hall 9 Rapid Oral 2636RO : Characterizing resistance mechanisms and predictors of early progression and long-term response to lorlatinib from the CROWN study. Findings suggest that baseline genomic complexity and on-treatment changes in methylation-based tissue-free assays may help identify patients at risk of early progression. Saturday, Oct. 24, 2026, Session: 8:30-10 a.m., Presentation: 9:05-9:10 a.m., Location: Almeria Auditorium - Hall 9 Poster 4403P : Using serial Guardant360 ® Liquid testing in a Phase 2 study with MD Anderson to examine clonal and subclonal resistance during anti-EGFR rechallenge in metastatic colorectal cancer to distinguish genuine resistance evolution from changes caused by fluctuating ctDNA levels, potentially improving patient selection for anti-EGFR rechallenge. Friday, October 23, 2026, Session: 3:15-4 p.m. Poster 2566P : Exploring post-surgical MRD and pathological complete response (pCR) after perioperative nivolumab in resectable Stage III NSCLC. In this exploratory analysis from NADIM II, pCR was associated with MRD negativity and excellent 5-year survival. In non-pCR patients, MRD negativity identified patients with favorable long-term outcomes, whereas detectable MRD defined a high-risk subgroup with early recurrence. Monday, October 26, 2026, Session: 12-12:45 p.m. Additional Guardant Health presentations at ESMO 2026 Abstract Full abstract title Session details Poster 424P Impact of blood draw weekday on turnaround time of Guardant360 ® CDx liquid biopsy: A real-world analysis Basic science Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 1026P Longitudinal ctDNA monitoring and radiological response to targeted therapies in early-phase clinical trials Developmental therapeutics Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 3275P Clinical utility and interpretation challenges of circulating comprehensive genomic profiling in routine oncology practice Pathology and molecular pathology Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 4279P Trastuzumab deruxtecan vs physician’s choice of chemotherapy in HR+, HER2-low metastatic breast cancer: A DESTINY-Breast06 ctDNA molecular response analysis Translational research and biomarkers Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 4311P Genomic landscape of cancer of unknown primary: Prognostic stratification through molecular profiling Translational research and biomarkers Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 4386P Beyond HER2 IHC: ERBB2 RNA-ISH stratifies benefit from T-DXd combinations Translational research and biomarkers Friday, October 23, 2026 Session: 3:15-4 p.m. Poster 8P Clinical efficacy and predictive biomarkers of mTOR inhibition combined with endocrine therapy following progression on PI3K inhibitors in hormone receptor–positive metastatic breast cancer Advanced breast cancer, other Saturday, Oct. 24, 2026 Session: 12-12:45 p.m. Poster 45P Real-world elacestrant outcomes in ESR1-mutant HR+/HER2− metastatic breast cancer: A two-center NHS audit Advanced breast cancer, other Saturday, October 24, 2026 Session: 12-12:45 p.m. Poster 708P Clinical and molecular characteristics of leptomeningeal disease in metastatic breast cancer patients: A prospective observational registry study CNS tumors Saturday, October 24, 2026 Session: 12-12:45 p.m. Rapid oral 787RO ctDNA-guided re-treatment with encorafenib and cetuximab in patients with chemorefractory BRAFV600E mutated metastatic colorectal cancer (mCRC): The proof-of-concept single arm phase II BRICKET trial by GONO Rapid oral: Gastrointestinal tumors, lower digestive Saturday, October 24, 2026 Session: 2:45-4:15 p.m. Presentation: 2:45-2:50 p.m. Location: Alicante Auditorium - Hall 6 Poster 805P Baseline ctDNA and the efficacy of staged combination with encorafenib + binimetinib + cetuximab following encorafenib + cetuximab in patients with BRAF V600E-mutant mCRC from BAYONET trial Colon cancer Sunday, October 25, 2026 Session: 12-12:45 p.m. Rapid oral 3718RO Molecular response in KIT circulating ctDNA from StrateGIST 1: A phase 1/1b study of velzatinib (IDRX-42) in patients with advanced gastrointestinal stromal tumors Rapid oral: Sarcoma Monday, October 26, 2026 Session: 8:30-10 a.m. Presentation: 8:35-8:40 a.m. Malaga Auditorium - Hall 3 LBA - 4037 ctDNA negative hyperselection as an effect modifier of treatment sequence efficacy in left-sided RAS wild-type mCRC: pre-specified exploratory analysis of the CR-SEQUENCE TBD LBA 2882eP ctDNA assessment in patients with CLDN18.2+, HER2−, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in SPOTLIGHT TBD ePoster- 2813eP A decade of ctDNA-NGS in NSCLC: Real-world evolution of actionability and liquid-first clinical use ePoster: NSCLC, metastatic ePoster- 4548eP Combined cfDNA and ctDNA analysis improves prognostic models in patients referred for early-phase clinical trials ePoster: Translational research and biomarkers ePoster- 2734eP Clinical significance of comprehensive genomic profiling after negative initial CDx testing in advanced NSCLC ePoster: NSCLC, metastatic ePoster TiP- 3584eTiP Consolidation XELOX plus dostarlimab after chemoradiation with optional adjuvant dostarlimab in pMMR/MSS or MSI-low locally advanced rectal cancer: The IMMUNOSTAR phase II randomized trial (GOIRC-02-2024) ePoster Trial in progress: Rectal and anal cancer ePoster- 2783eP Sequential liquid biopsy in advanced NSCLC ePoster: NSCLC, metastatic ePoster- 4185eP The value of liquid biopsy in pleural mesothelioma as a biomarker strategy in clinical trials selection ePoster: Thoracic malignancies, other The full abstracts for Guardant Health at ESMO 2026 can be found on the ESMO website . Since 2020, Guardant has established public-private partnerships (PPPs) with leading healthcare institutions and cancer centers in Europe including The Royal Marsden NHS Foundation Trust (UK), Vall d’Hebron Institute of Oncology (Spain), and Policlinico Gemelli (Italy) to localize advanced diagnostic testing, generate clinical/economic evidence, and ultimately expand reimbursement and adoption. These partnerships make it possible to deliver high quality, clinical grade testing, similar to tests administered in the U.S., with local validation supporting research, delivering faster diagnoses, and increasing access to targeted treatments. To learn more about the PPPs and Guardant Health during ESMO, visit the team at Booth #8058. About Guardant360 ® Liquid Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing comprehensive genomic profiling (CGP) to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts. About Guardant Reveal ® Guardant Reveal is a tissue-free liquid biopsy test that detects minimal residual disease (MRD) and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights. The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures. About Guardant360 ® CDx Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Contacts Investor Contact: Zarak Khurshid investors@guardanthealth.com Media Contact: Meaghan Smith press@guardanthealth.com

Phase 2Clinical Result

16 Sep 2026

·www.fiercebiotech.com

Novo explores macrocycles’ potential in $1.4B cardiometabolic pact with Danish biotech

Novo’s race to rejuvenate its cardiometabolic portfolio has seen the rebranded Danish pharma pen a $1.4 biobucks pact with oral macrocycle drug start-up Orbis Medicines. The deal will focus on developing next-generation orally bioavailable macrocycle therapies aimed at “high-value” targets for cardiometabolic diseases, the companies explained in a Sept. 17 release. The precise number or nature of the targets was not disclosed. The partners didn’t offer a breakdown of the financials, but did say that the upfront payment and milestone payouts potentially coming Orbis’ way could total $1.4 billion. Novo—which rebranded from Novo Nordisk on Monday—will also make a strategic investment in Orbis, which is likewise headquartered in the Danish capital of Copenhagen. The agreement marks the first Big Pharma pact for Orbis. The biotech was founded by Novo Holding, an investment firm that is also Novo’s controlling majority shareholder. Orbis has raised 116 million euros ($134 million) since 2024 through a combination of seed financing and a series A backed by Eli Lilly’s VC arm. The biotech’s stated aim has been to pioneer a “new era for oral macrocycle drug discovery.” Macrocycles are ring-shaped molecules that can alter protein interactions. While small molecules usually contain rings of five to seven atoms and are relatively inflexible, macrocycles normally contain 12 or more atoms. Among the dozens of approved macrocycles are certain radiopharmaceuticals like Novartis’ Lutathera, cyclic peptide drugs like Rhythm Pharmaceuticals’ Imcivree and Pfizer’s tyrosine kinase inhibitor Lorbrena for lung cancer. In recent years, macrocycles have been of particular interest in the cardiometabolic space. In February, Novartis penned a $100 million biobucks pact to work with Unnatural Products on macrocycles for cardiovascular disease, while Japan’s PeptiDream demonstrated last year that its oral macrocyclic peptides preserved lean muscle mass in mice given Novo’s Wegovy. Orbis has been using its AI-enabled nGen platform to create oral macrocycle drug candidates, dubbed nCycles, which are suitable for both intra- and extracellular targets. “Our nGen platform continuously learns from data generated by our high-throughput chemistry and screening platform to design orally bioavailable macrocycles with the potential to replace injectable medicines,” Orbis CEO Morten Graugaard said in the release. “Together with Novo, we have an opportunity to unlock a new generation of oral medicines for cardiometabolic diseases and demonstrate the transformative potential of AI-enabled macrocycle drug discovery.” Novo has made no secret of the fact that it's still on the hunt to fill gaps in its cardiometabolic pipeline after a series of setbacks. The Wegovy-maker abandoned another attempt to develop a monthly GLP-1 drug on Monday. Last week the company gave up on two more phase 3 trials of ziltivekimab, further eroding the prospects for a molecule that analysts had once tipped as a potential inflammation blockbuster. “We believe this collaboration has the potential to unlock innovative oral treatment options for patients with cardiometabolic diseases while expanding the possibilities of macrocycle therapeutics,” Brian Vandahl, Senior Vice President, Therapeutics Discovery, Novo, said in the release.

24 Aug 2026

·www.pharmaceutical-technology.com

Immunology specialist Khartis Therapeutics emerges from stealth with $95m

Khartis said the financing would support its pipeline of oral small molecule medicines targeting immunology pathways. Credit: Maryia Blizniakova/Shutterstock.com. Armed with $95m in funding and a former Pfizer drug discovery specialist, Khartis Therapeutics has emerged with the aim of bringing a new treatment for an autoimmune disease that causes eye inflammation. Unveiling itself via a $50m Series B raise announcement, Khartis said its pipeline includes oral small-molecule medicines with both first- and best-in-class potential targeting immunology pathways. The fundraise, which was led by Forge Life Science Partners with participation from existing investors including Lilly Asia Ventures, means the biotech has amassed $95m in capital. Khartis said the financing would support its pipeline of oral small molecule medicines targeting immunology pathways. In particular, capital will be directed towards its lead programme, an oral, selective IGF-1R inhibitor designed specifically for the treatment of thyroid eye disease (TED). TED is an autoimmune condition that causes inflammation, swelling, and a bulging appearance of the eyes. While closely linked to Graves’ disease and overactive thyroids, patients can still have the disease with normal thyroids. While targeted biologic drugs are approved to treat TED, including Amgen’s blockbuster Tepezza (teprotumumab) and Viridian Therapeutics’ Lumvoa (veligrotug), Khartis claims these come with safety trade-offs. For example, both drugs can cause severe hearing issues and spikes in blood sugar. Like Khartis’ candidate, both Amgen and Viridian’s products are IGF-1R inhibitors, though these are administered as intravenous infusions. To join the market, Khartis says it will offer a safer and more durable patient-friendly option. Khartis was co-founded in 2024 by Robert Hoffman, a veteran of the biopharma sector. Hoffman spent 32 years at Pfizer as a research project leader, helping discover lung cancer therapy Lorbrena (lorlatinib) and Covid-19 antiviral Lufotrelvir, amongst others. He also served as vice president of chemistry at XinThera until the biotech was acquired by Gilead for an undisclosed sum in May 2023. Hoffman has taken the mantle of CEO and head of drug discovery at Khartis, while co-founders Craig Murphy and Chris LeMasters are the CSO and executive chairman, respectively. The three founders, along with several of Khartis’ scientific team, worked together at XinThera. Following the emergence from stealth, Hoffman said: “This financing reflects strong conviction in our team, our science, and the opportunity ahead. With this backing, we will accelerate advancement of our lead programme while continuing to do what this team does best: discovering and developing differentiated small molecule medicines against important, clinically validated targets.” Murphy highlighted the “serious burden” that remains for TED patients, explaining that its lead programme represents just the first in a broad pipeline. “We believe an oral, selective IGF-1R inhibitor can change that equation, helping to substantially open the market with a safer, more durable patient-friendly option. And this is just the first programme in a pipeline we’re excited to bring forward,” he commented. The content above comes from the network. if any infringement, please contact us to modify.

AcquisitionExecutive Change

100 Deals associated with Lorlatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11012	Lorlatinib	L01ED05	DB12130

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	United States	Pfizer Inc.	02 Nov 2018
Non-Small Cell Lung Cancer	Japan	Pfizer Inc.	21 Sep 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Marginal Zone Lymphoma	Phase 2	United States	Pfizer Inc.	01 May 2020
ALK-positive anaplastic large cell lymphoma	Phase 2	Italy	Pfizer Inc.	28 Sep 2019
Anaplastic Large-Cell Lymphoma	Phase 2	Italy	Pfizer Inc.	28 Sep 2019
metastatic non-small cell lung cancer	Phase 2	United States	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	Japan	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	Australia	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	South Korea	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	Spain	Pfizer Inc.	18 Dec 2015
Advanced Lung Non-Small Cell Carcinoma	Phase 2	United States	Pfizer Inc.	08 Jan 2014
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Japan	Pfizer Inc.	08 Jan 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	Ovarian Cancer \| Breast Cancer \| Prostatic Cancer ... View more	1,112	trifluridine/tipiracil	agllpxqokp(mdkllhtznx) = agqavjotqz bruxtmrscy (phggpaanls ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable		1,112	lorlatinib	agllpxqokp(mdkllhtznx) = dedixztyil bruxtmrscy (phggpaanls )	Positive	23 Oct 2026
ESMO2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer	26	Lorlatinib	mttndjpydr(bibdfqbzzc) = most commonly because of dyslipidaemia gkqmwymhvr (sefrehoosq ) View more	Positive	23 Oct 2026
NCT03052608 (CROWN, ESMO2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer ALK+	296	Lorlatinib 100 mg QD	rvjsajqfjd(nyvlqkcwfo) = ktytaagxfd etswvuwkcw (qsnxosmhts )	Positive	23 Oct 2026
NCT03052608 (CROWN, ESMO2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer ALK+	296	Crizotinib 250 mg BID	rvjsajqfjd(nyvlqkcwfo) = zbvkgbonat etswvuwkcw (qsnxosmhts )	Positive	23 Oct 2026
ESMO2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer	26	Lorlatinib	omriotrzth(nsdmfnzjap) = ixtanwydsw tshejpnglu (gsblcefbxw ) View more	Positive	23 Oct 2026
NCT06282874 (PEARL/CTONG2303, ESMO2026)	Phase 2	Non-Small Cell Lung Cancer ALK+	41	Lorlatinib 100 mg daily (BM cohort)	rnhtbleanj(gdbraxqamh) = bjtwaufjra xvtpbjchih (wggsukswlm ) View more	Positive	23 Oct 2026
NCT06282874 (PEARL/CTONG2303, ESMO2026)	Phase 2	Non-Small Cell Lung Cancer ALK+	41	Lorlatinib 100 mg daily (LM cohort)	rnhtbleanj(gdbraxqamh) = nqxvbctyqx xvtpbjchih (wggsukswlm ) View more	Positive	23 Oct 2026
ROYAL (ESMO2026)	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line ALK+	74	Lorlatinib	vezewtrswb(baykcgtrta) = ktyotitgqb relyuydoej (kyivavzfqm ) View more	Positive	23 Oct 2026
NCT03052608 (CROWN, WCLC2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK+	291	Lorlatinib 100 mg once daily	ihclvmdzpx(mqejzjmacc) = zilelvmnqn nxhnoglnil (qofzdnvrca, 68.5 - NR) View more	Positive	12 Sep 2026
NCT03052608 (CROWN, WCLC2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK+	291	Crizotinib 250 mg twice daily	ihclvmdzpx(mqejzjmacc) = eegcpfmmqd nxhnoglnil (qofzdnvrca, 7.4 - 10.9) View more	Positive	12 Sep 2026
WCLC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	18	Lorlatinib 100 mg	rdmlsdjjpl(aghvektsem) = ikrmkoenlh htphekgrko (bfvsguliyi ) View more	Positive	12 Sep 2026
WCLC2026	Not Applicable	Non-Small Cell Lung Cancer	37	Lorlatinib	ovmsdnlrls(gdbxcqggyt) = HDL remained largely stable ejvqujgupp (qslkyjjavx ) View more	Positive	12 Sep 2026
NCT03052608 (CROWN, WCLC2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer ALK+	149	Lorlatinib 100 mg	ikgmwrdpxc(niicazmech) = gnhldynzpb flksrhgqnx (nrcjlwqczj ) View more	Positive	12 Sep 2026

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis