Delving into the Latest Updates on Lorlatinib with Synapse

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

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Structure/Sequence

Molecular FormulaC21H19FN6O2

InChIKeyIIXWYSCJSQVBQM-LLVKDONJSA-N

CAS Registry1454846-35-5

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-

NCT07784959

/ RecruitingPhase 1

A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer

This is a multi-center, open label, Phase 1b study of NXP900 in combination with lorlatinib in subjects with advanced, ALK-positive non-small cell lung cancer (NSCLC)

Start Date17 Aug 2026

Sponsor / Collaborator

Nuvectis Pharma, Inc.

NCT07617337

/ Not yet recruitingPhase 1

A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.

Start Date24 Jul 2026

Sponsor / Collaborator

Chugai Pharmaceutical Co., Ltd.

100 Clinical Results associated with Lorlatinib

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100 Translational Medicine associated with Lorlatinib

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100 Patents (Medical) associated with Lorlatinib

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919

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: Novelli, Giuseppe ; Pasello, Giulia ; Rumi, Filippo ; Di Virgilio, Roberto ; Basile, Michele ; Bearz, Alessandra ; 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

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.

31 Dec 2026·Lung Cancer Management

Cost of managing brain metastases in patients with ALK+ advanced NSCLC with first-line tyrosine kinase inhibitors in the UK

Article

Author: Rifi, Nada ; Lowry, Chrissy ; Baijal, Shobhit ; Le, Hannah ; Ladino, Daniel

INTRODUCTION:

This study aimed to estimate the NHS costs of managing patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small-cell lung cancer (aNSCLC), with and without brain metastases. Patients were treated with first-line (1 L) ALK tyrosine kinase inhibitors (TKIs).

METHODS:

We built an economic model to estimate the annual costs of managing ALK+ aNSCLC patients with and without brain metastases using estimated NHS health care resource use (HCRU) consumption. The ALK TKIs included in our model were lorlatinib, crizotinib, alectinib and brigatinib. We based our estimates on the cumulative incidence of brain metastases in four clinical trials - CROWN, ALEX, ALESIA and ALTA-1L.

RESULTS:

For the first year of treatment, our model estimated the annual cost of managing patients with brain metastases to be £14,870. Patients without brain metastases cost £4,133. The NHS HCRU cost savings generated by treating patients with lorlatinib increased significantly over time and were greater in patients without brain metastases at the start of their treatment (at baseline) with lorlatinib. This reflects the prevention of brain metastases with 1 L lorlatinib.

CONCLUSION:

The longitudinal cost data demonstrate that lorlatinib leads to potentially lower NHS management costs of brain metastases in patients with ALK+ aNSCLC.

96

News (Medical) associated with Lorlatinib

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

04 Aug 2026

·www.pharmaceutical-technology.com

GSK secures first lung cancer approval, validating $10.6bn Nuvalent bet

Just days after completing a $10.6bn takeover of lung cancer biotech Nuvalent, GSK is already reaping the rewards with Jideytro (zidesamtinib) having gained US approval in ROS1-positive non-small cell lung cancer (NSCLC). This means the selective ROS1 kinase inhibitor is now indicated for use in American adults with locally advanced or metastatic ROS1-positive NSCLC, provided they have already previously received treatment with a prior ROS1 kinase inhibitor. This is GSK’s first drug for lung cancer to make it to market. The US Food and Drug Administration (FDA) opted to approve Jideytro based on the results of the single-arm Phase I/II ARROS-1 study (NCT05118789), in which the drug triggered an objective response rate (ORR) of 44% in the overall patient population, which included patients with brain metastases and ROS1 resistance mutations. GSK acquired the rights to Jideytro and fellow late-stage lung cancer candidate through its multi-billion-dollar acquisition of Massachusetts-based biotech, Nuvalent, which closed on 15 July 2026. According to the British pharma company, Jideytro has been specifically designed to overcome the challenges linked to approved therapies in this indication – including the acquisition of ROS1 resistance mutations following treatment, as well as inefficient blood-brain barrier penetration for patients with brain metastases. Jideytro will now join Pfizer’s ROS1-positive NSCLC therapy, Lorbrena (lorlatinib), on the market, which achieved blockbuster status in 2025. Currently, analysts from GlobalData estimate that Lorbrena sales will increase at a compound annual growth rate of 8.3% between 2025 and 2032. As GSK makes its first foray into the lung cancer space, it is also betting on the potential of other candidates from the Nuvalent acquisition that could bolster its positioning in the space. This includes neladalkib, an ALK-selective tyrosine kinase inhibitor, which is currently under review by the US Food and Drug Administration (FDA), with the agency expected to make a call on the drug’s market future on 27 November 2026. Another less developed asset GSK acquired from the Nuvalent acquisition was HER2-altered NSCLC candidate, NVL-330, which is currently being evaluated in a Phase I trial. In a previous research note, Jefferies analysts noted that the Nuvalent acquisition adds “highly profitable” assets with a long duration of therapy plus an ability to move up the treatment cascade. They add that these assets also carry “meaningful revenue potential into the post-2030 period”. This comes as the company contends with key upcoming patent expiries within its HIV medicines portfolio – including Tivicay (dolutegravir), which is expected to lose its market exclusivity in 2028. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultAcquisitionDrug Approval

04 Aug 2026

·www.fiercepharma.com

Pfizer unveils additional $2.5B in planned cost savings through 2029

Pfizer will reduce its costs by $2.5 billion in another round of cutbacks, which will kick in next year and run through 2029. The New York company unveiled the plan in its second-quarter earnings report (PDF). The savings effort comes amid a quarter in which Pfizer topped expectations with a 3% revenue increase to $15 billion. The company raised its 2026 sales guidance at the midpoint by $500 million to a range of $60.5 billion to $62.5 billion. The additional cutbacks bring Pfizer’s total cost-savings target (PDF) to $9.7 billion through 2029. Of the new $2.5 billion effort, $1.5 billion is earmarked for optimizing the company’s manufacturing operations, with the remaining $1 billion added to Pfizer’s “cost realignment program.” In total, the cost realignment plan is designed to save the company $6.7 billion through the end of 2029. Pfizer is churning $500 million of the cost savings into R&D investment this year, it added. The manufacturing optimization effort is “focused on network structure changes, product portfolio enhancements and additional operational efficiencies,” Pfizer said. Overall, the cost savings will support “margin expansion through productivity gains” and provide “future growth opportunities,” Pfizer added. To install and execute the new cost savings, Pfizer will incur a one-time expenditure of $6 billion, with much of the figure going to severance, implementation and exit costs, in addition to non-cash expenditures for accelerated depreciation and asset write-downs. The program is a continuation of Pfizer’s reorganization, which kicked off in 2023 following its $43 billion acquisition of antibody-drug conjugate specialist Seagen. The buyout expanded Pfizer’s headcount to 88,000 at the end of that year and has since been in decline, falling to 75,000 at the end of 2025. As for Pfizer’s quarterly revenue surprise, analysts had expected a year-over-year decline, given the company’s 10% sales boom in the second quarter of 2025, which was attributed to contractual arrangements for the COVID products Comirnaty and Paxlovid. While the COVID products saw major dropoffs, including Paxlovid sales plummeting from $427 million in the second quarter of last year to $21 million in the same period this year, Pfizer’s growth products thrived, including blood thinner Eliquis, which was up 21%, and migraine therapy Nurtec, which saw an 18% increase. Pfizer’s cancer medications that were up included Orgovyx (+51%), Lorbrena (+41%) and Padcev (+23%), helping the oncology portfolio to a 9% bump. Even in the face of new competition from Alnylam and BridgeBio in ATTR-CM, Pfizer’s Vyndaqel family of drugs realized a 9% gain. Another positive was the rebound of RSV shot Abrysvo, which was up 46%. Interim chief financial officer Cecile Guegan said that Pfizer’s upgraded revenue guidance “reflects strong non-COVID product performance.” The uptick includes a $1.5 billion increase in expected sales from non-COVID products, along with a $1 billion reduction in the company’s projection of its COVID product sales, from $5 billion to $4 billion. “The performance that we have to date reflects the low infection level, mostly impacting Paxlovid,” Guegan added on a conference call Tuesday. “But we remain with our revenues for Comirnaty in the later part of the year, consistent with the vaccination season.”

Acquisition

100 Deals associated with Lorlatinib

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External Link

KEGG	Wiki	ATC	Drug Bank
D11012	Lorlatinib	L01XE44	DB12130

R&D Status

Approved

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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.

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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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_Breakthrough2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	1,688	Lorlatinib	jrnzhlvvzg(jctkswmfop) = ougxflgtsg qeehgyfatw (kjvywwsbac ) View more	Positive	25 Jun 2026
				Alectinib	jrnzhlvvzg(jctkswmfop) = opclidwjng qeehgyfatw (kjvywwsbac ) View more
NCT03052608 (CROWN, ASCO2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK+	296	Lorlatinib 100 mg once daily	neakvfhiwd(ckkbkuhuak) = Treatment-related AEs (TRAEs) led to permanent treatment discontinuation in 5% of pts with lorlatinib and 6% with crizotinib iesgnfmhhw (abuyonfvlr ) View more	Positive	29 May 2026
				Crizotinib 250 mg twice daily
ASCO2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	82	Lorlatinib	ksgpqfwhna(slvskxakfj) = xmafnhduwo knhpbyvckp (nnxltknewb, NR - NR) View more	Positive	29 May 2026
NCT05740943 (LORIN, ASCO2026)	Phase 2	Non-small cell lung cancer stage III Neoadjuvant ALK fusion	43	Lorlatinib	nrkkrndmpr(okpphzmduy) = yatlbdydot qanhnfzajv (mbyrsjcqjr ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	ALK positive Lung Cancer	35	Lorlatinib 25 mg	aaqmqmexgr(pmscvcthau) = kmbyozzrgr qbfpdvgobp (oxjfgmboyy ) View more	Positive	29 May 2026
NCT04362072 (Pubmed \| Future Oncol)	Phase 4	Second line ALK-positive	71	Lorlatinib 100 mg once daily	swbaugxaxv(yjutcfrref) = lfmvnqgcuj ekwvsfyisy (efkncgotyj, 31 - 55) View more	Positive	21 Apr 2026
				Lorlatinib 100 mg once daily (central nervous system metastases)	swbaugxaxv(yjutcfrref) = upxkynofqr ekwvsfyisy (efkncgotyj )
AACR2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line ALK-positive	60	Lorlatinib (good response)	kuozynpuix(kvukyrdlef) = bbsavclptb aaqwugibrt (qmwzuluscr ) View more	Positive	19 Apr 2026
				Lorlatinib (limited response)	kuozynpuix(kvukyrdlef) = zfzjikiyay aaqwugibrt (qmwzuluscr ) View more
ESMO_ELCC2026	Not Applicable	Non-Small Cell Lung Cancer	170	Lorlatinib (ALK+ or ROS1+ NSCLC + long responders)	bnrdzvkeuk(tmmkkxtebu) = nvtttzuppl ermpgjobmt (ltiqfnmgfa ) View more	Positive	25 Mar 2026
ESMO_ELCC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer	146	Lorlatinib	ythrilpojc(kusgvpjmif) = grmgdaxnor nmlnrascut (dmxfbaaony ) View more	Positive	25 Mar 2026
				Brigatinib	ythrilpojc(kusgvpjmif) = ypgdnxuuil nmlnrascut (dmxfbaaony ) View more
ESMO_ELCC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	108	First-line lorlatinib	udowqjawet(pgqxmrhfdr): HR = 0.32 (95.0% CI, 0.15 - 0.67), P-Value = 0.003 View more	Positive	25 Mar 2026
				Sequential second-generation ALK TKI followed by lorlatinib