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Last update 10 Apr 2025
Rilvegostomig
Last update 10 Apr 2025
Overview
Basic Info
Drug Type Bispecific antibody |
Synonyms AZD 2936, AZD-2936 |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors), TIGIT inhibitors(T cell immunoglobulin and ITIM domains inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 18899517L
Source: *****
Sequence Code 18899526H
Source: *****
Sequence Code 719888445H
Source: *****
Sequence Code 719888446L
Source: *****
Related
38
Clinical Trials associated with RilvegostomigNCT06921785
A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
Start Date16 May 2025 |
Sponsor / Collaborator |
NCT06868277
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
Start Date15 Apr 2025 |
Sponsor / Collaborator |
CTR20244980
一项在肿瘤表达PD-L1的转移性非鳞状非小细胞肺癌患者中对比一线Rilvegostomig或帕博利珠单抗联合含铂化疗的随机、双盲、多中心、全球、III期研究
[Translation] A randomized, double-blind, multicenter, global, phase III study comparing first-line rivegostomig or pembrolizumab plus platinum-based chemotherapy in patients with metastatic nonsquamous non-small cell lung cancer whose tumors express PD-L1
试验目的是评估rilvegostomig联合化疗与帕博利珠单抗联合化疗相比1L治疗肿瘤表达PD-L1（TC≥1%）的非鳞状细胞mNSCLC参与者的有效性和安全性。主要目的是通过评估OS和PFS，证明rilvegostomig + 化疗相较于帕博利珠单抗 + 化疗的有效性。
[Translation]
The trial aims to evaluate the efficacy and safety of rilvegostomig plus chemotherapy compared with pembrolizumab plus chemotherapy in 1L treated participants with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%). The primary objective is to demonstrate the efficacy of rilvegostomig + chemotherapy compared with pembrolizumab + chemotherapy by evaluating OS and PFS.
Start Date18 Mar 2025 |
Sponsor / Collaborator |
100 Clinical Results associated with Rilvegostomig
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100 Translational Medicine associated with Rilvegostomig
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100 Patents (Medical) associated with Rilvegostomig
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1
Literatures (Medical) associated with RilvegostomigPOSTGRADUATE MEDICAL JOURNAL
Volrustomig/Rilvegostomig related “triple M”—myasthenia gravis and overlap syndrome
Article
Author: Weaver, Jamie M J ; Keh, Ryan Y S ; Cooksley, Tim
106
News (Medical) associated with Rilvegostomig07 Mar 2025
MATTERHORN is first global, randomised Phase III trial to demonstrate superior event-free survival with an immunotherapy combination over standard of care in this setting
Imfinzi plus chemotherapy more than doubled pathologic complete response rate in previously reported analysis of this trial in 2023
LONDON, UK I March 07, 2025 I
Positive high-level results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s
Imfinzi
(durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS). Patients were treated with neoadjuvant
Imfinzi
in combination with chemotherapy before surgery, followed by adjuvant
Imfinzi
in combination with chemotherapy, then
Imfinzi
monotherapy. The trial evaluated this regimen versus perioperative chemotherapy alone for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
For the secondary endpoint of overall survival (OS), a strong trend was observed in favour of the
Imfinzi-
based regimen at this interim analysis. The trial will continue to follow OS, which will be formally assessed at the final analysis.
Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year.
1
In 2024, there were roughly 43,000 drug-treated patients in the US, European Union (EU) and Japan in early-stage and locally advanced gastric or GEJ cancer.
2
Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030.
3
Yelena Y Janjigian, MD, Chief Attending Physician of the Gastrointestinal Medical Oncology Service, Memorial Sloan Kettering Cancer Center, New York and principal investigator in the trial, said: “Despite receiving curative-intent chemotherapy and surgery, patients with gastric cancer commonly face disease recurrence and have a poor prognosis. These exciting data from MATTERHORN show that a durvalumab-based perioperative regimen resulted in a clinically meaningful improvement in patient outcomes, including decreasing the risk of the cancer coming back.”
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “MATTERHORN is the first Phase III trial of an immunotherapy to show a statistically significant improvement in event-free survival in patients with resectable gastric and gastroesophageal junction cancers. This perioperative approach with
Imfinzi
underscores our commitment to moving into earlier stages of cancer where novel therapies can have the biggest impact on patients’ lives.”
The safety profile for
Imfinzi
and FLOT chemotherapy was consistent with the known profiles of each medicine, and there were no new safety findings.
In a
previously reported
interim analysis for the key secondary endpoint of pathologic complete response (pCR), the
Imfinzi
combination more than doubled the pCR rate compared to neoadjuvant chemotherapy alone (19% versus 7%, odds ratio 3.08; p<0.00001).
4
Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
Notes
Gastric and gastroesophageal junction cancers
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.
1
In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.
5
Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.
1
GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.
6
Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy. Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and one in four patients do not survive beyond two years, reflecting high unmet medical need.
7-8
Additionally, the five-year survival rate remains poor, with less than half of patients alive at five years.
9
MATTERHORN
MATTERHORN is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating
Imfinzi
as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomised to receive a 1500mg fixed dose of
Imfinzi
plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by
Imfinzi
or placebo every four weeks for up to 12 cycles after surgery (including two cycles of
Imfinzi
orplacebo plus FLOT chemotherapy and 10 additional cycles of
Imfinzi
or placebo monotherapy).
In the MATTERHORN trial, the primary endpoint is EFS, defined as the time from randomisation until progression that precludes surgery or requires non-protocol therapy, local or distant recurrence or progression of disease, or death due to any cause as assessed by blinded independent central review (BICR) according to RECIST 1.1 and/or local pathology testing. Key secondary endpoints include pCR rate, defined as the proportion of patients who have no detectable cancer cells in resected tumour tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centres in 20 countries, including in the US, Canada, Europe, South America and Asia.
Imfinzi
Imfinzi
(durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.
Imfinzi
is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer (BTC) and in combination with
Imjudo
(tremelimumab) in unresectable hepatocellular carcinoma (HCC).
Imfinzi
is also approved as a monotherapy in unresectable HCC in Japan and the EU.
In addition to its indications in GI cancers,
Imfinzi
is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally,
Imfinzi
is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable non-small cell lung cancer (NSCLC), and in combination with a short course of
Imjudo
and chemotherapy for the treatment of metastatic NSCLC.
Imfinzi
is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.
Imfinzi
in combination with chemotherapy followed by
Imfinzi
monotherapy is approved as a 1
st
-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU).
Imfinzi
in combination with chemotherapy followed by
Lynparza
(olaparib) and
Imfinzi
is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.
Since the first approval in May 2017, more than 374,000 patients have been treated with
Imfinzi
. As part of a broad development programme,
Imfinzi
is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several GI and gynaecologic cancers, and other solid tumours.
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.
10
Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers.
In addition to its indications in BTC and HCC,
Imfinzi
is being assessed in combinations, including with
Imjudo
, in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.
The Company is also assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers.
Enhertu
(trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is approved in the US and several other countries for HER2-positive advanced gastric cancer.
Enhertu
is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Lynparza
, a first-in-class PARP inhibitor, is approved the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer.
Lynparza
is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).
AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include AZD0901, a potential first-in-class antibody drug conjugate licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD6422, an armoured autologous chimeric antigen receptor T-cell (CAR T) therapy, currently being evaluated in an Investigator Initiated Trial (IIT) in collaboration with AbelZeta in China.
In early development, AstraZeneca is developing two Glypican 3 (GPC3) armoured CAR Ts in HCC. AZD5851, currently in Phase I development, is being developed globally, and C-CAR031 / AZD7003 is being co-developed with AbelZeta in China where it is under evaluation in an IIT.
AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with
Imfinzi
as a monotherapy and in combination with
Imjudo
as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit
astrazeneca.com
and follow the Company on social media
@AstraZeneca
.
References
SOURCE:
AstraZeneca
ImmunotherapyClinical ResultPhase 3Drug ApprovalPhase 1
06 Mar 2025
With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation.
LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's "
TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
EMD Serono's TEPMETKO (tepotinib) Overview
TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment.
Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation.
The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time.
Learn more about TEPMETKO projected market size for NSCLC @
TEPMETKO Market Potential
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently,
80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around
80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations.
Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI),
KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by
TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of
OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC.
According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from
USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034).
Discover more about the NSCLC market in detail @
Non-small Cell Lung Cancer Market Report
Emerging Competitors of TEPMETKO
The NSCLC pipeline is very robust with the promising therapies such as
Telisotuzumab vedotin (AbbVie),
Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca),
Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca),
Eftilagimod alpha (Immutep),
BNT311/GEN1046 (acasunlimab) (Genmab),
V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck),
Plinabulin + Docetaxel (BeyondSpring),
Olomorasib (LY3537982) (Eli Lilly and Company),
Zipalertinib (Cullinan Oncology/Taiho Pharma),
Ceralasertib (AZD6738) (AstraZeneca),
TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics),
Sigvotatug vedotin
(PF08046047) (Pfizer),
ANKTIVA (N-803) (ImmunityBio),
Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical),
Niraparib (GSK),
Savolitinib (AstraZeneca/Hutchison MediPharma),
TRODELVY (Gilead Sciences),
Pyrotinib (Jiangsu HengRui Medicine),
Ociperlimab (BGB-A1217) (BieGene),
Volrustomig (AstraZeneca),
Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech),
Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics),
ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics),
Divarasib (GDC-6036) (Roche/Genentech),
Tiragolumab (RG6058) (Roche),
Sacituzumab Tirumotecan (Merck and Kelun-Biotech),
JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio),
Zongertinib (BI-1810631) (Boehringer Ingelheim),
BAY 2927088 (Bayer),
Serplulimab (HLX10) (Shanghai Henlius Biotech),
Rilvegostomig (AZD2936) (AstraZeneca),
MK-1084 (Merck, Taiho Pharmaceutical, and Astex),
Domvanalimab (Arcus Biosciences and Gilead Sciences),
OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb),
Belrestotug + JEMPERLI (iTeos Therapeutics and GSK),
Firmonertinib (ArriVent BioPharma),
Sunvozertinib (DZD9008) (Dizal Pharmaceutical),
Cobolimab (GSK),
Livmoniplimab (AbbVie),
Fianlimab (REGN3767) (Regeneron Pharmaceuticals),
BNT327/PM8002 (Biotheus/BioNTech),
HS-20117 (Hansoh BioMedical),
IO102-IO103 + Pembrolizumab (IO Biotech),
Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech),
FF-10832 (FUJIFILM Corporation),
BNT116 (BioNTechSE/Regeneron Pharmaceuticals),
CAN-2409 (Candel Therapeutics),
Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla),
Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals),
DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku),
Lifileucel (Iovance Biotherapeutics),
IBI363 (Innovent Biologics),
Sotevtamab (AB-16B5) (Alethia Biotherapeutics),
Avutometinib (VS6766) (Verastem Oncology),
Vebreltinib (APL-101) (Apollomics),
LP-300 (Lantern Pharma),
JNJ-90301900 (Johnson & Johnson Innovative Medicine),
AMG 193 (Amgen),
Luveltamab tazevibulin (Sutro Biopharma),
PRT3789 (Prelude Therapeutics),
Disitamab vedotin (Seagen),
PADCEV (enfortumab vedotin) (Astellas Pharma),
RP1 (Replimune),
TIVDAK (tisotumab vedotin) (Seagen),
Zanidatamab (Jazz Pharmaceuticals),
Utidelone injectable
(UTD1) (Beijing Biostar Pharmaceuticals),
REGN5093-M114 (Regeneron Pharmaceuticals),
SLC-391 (SignalChem Lifesciences),
fulzerasib (GenFleet),
Davutamig (REGN5093) (Regeneron Pharmaceuticals),
TAS3351 (Taiho Oncology),
H002 (RedCloud Bio),
JIN-A02 (J INTS BIO),
FWD1509 (Forward Pharma),
Sabestomig (AZD7789) (AstraZeneca),
Sasanlimab (Pfizer),
Selvigaltin (GB1211) (Galecto Biotech),
Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical),
EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech),
Pamvatamig (MCLA-129) (Merus),
Zidesamtinib (NVL-520) (Nuvalent),
NVL-655 (Nuvalent),
RMC-4630 (Revolution Medicines),
REQORSA (quaratusugene ozeplasmid) (Genprex),
PDC*lung01 (PDC*line Pharma),
Evalstotug (BA3071) (BioAtla and BeiGene),
PT-112 (Promontory Therapeutics),
MRT-2359 (Monte Rosa Therapeutics),
GAIA-102 (GAIA BioMedicine),
Rigosertib (Traws Pharma),
HMBD-001 (Hummingbird Bioscience),
PLB1004 (Avistone Biotechnology),
ANS03 (Avistone Biotechnology),
MYTX-011 (Mythic Therapeutics),
A166 (Sichuan Kelun-Biotech Bio-pharmaceutical),
Atamparib (BN-2397) (Ribon Therapeutics),
DELTACEL (KB-GDT-01) (Kiromic BioPharma),
Carotuximab (ENV-105) (Kairos Pharma),
YL202 (MediLink Therapeutics), and others.
To know more about the number of competing drugs in development, visit @
TEPMETKO Market Positioning Compared to Other Drugs
Key Milestones of TEPMETKO
In
February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations.
In
February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
In
February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR.
In
October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations
In
March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations.
In
September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy
Discover how TEPMETKO is shaping the NSCLC treatment landscape @
TEPMETKO NSCLC
TEPMETKO Market Dynamics
TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their
efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available,
enabling better identification of patients who would benefit from targeted treatments like TEPMETKO.
A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with
Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of
once-daily dosing compared to TABRECTA's
twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally,
broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position.
Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but
reimbursement and pricing strategies vary by market. Payer policies, along with the
cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore,
real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration.
Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on
continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape.
Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @
TEPMETKO Market Drug Report
Table of Contents
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C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including
AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others.
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Drug ApprovalImmunotherapyPriority Review
04 Mar 2025
Clinical data presented at SITC 2024 supports further development of COM701, potential first-in-class anti-PVRIG antibody
On track to initiate a randomized adaptive platform trial of COM701 maintenance therapy in patients with platinum sensitive ovarian cancer, scheduled to start in Q2 2025
The first patient was dosed in Q1 2025 in the first in human Phase 1 solid tumor trial of GS-0321 (previously COM503), a potential first-in-class anti-IL18BP antibody licensed to Gilead
Partner AstraZeneca reported promising rilvegostomig data in 2024, expanded the rilvegostomig program to seven Phase 3 trials across lung and gastrointestinal cancers and plans to share early data for rilvegostomig in combination with their ADCs in 2025
Solid financial position with cash runway expected to fund operations into 2027
HOLON, Israel, March 4, 2025 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today reported financial results for the fourth quarter and full year 2024 and provided a corporate update.
"I believe Compugen is well-positioned for growth, building on significant progress made in 2024 together with a diverse and innovative pipeline and with a strong focus on execution in 2025," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The clinical data we presented at SITC 2024, consistent with previous data, support advancing our potential first-in-class anti-PVRIG, COM701, to be evaluated as a maintenance treatment option for patients with platinum sensitive ovarian cancer. We are on track to initiate an adaptive platform trial, which is scheduled to start with a randomized placebo controlled sub-trial evaluating single agent COM701 therapy in Q2 2025. This development path is supported by a strong clinical and biological rationale and has the potential to open the door to advance COM701 as a single agent and as a backbone to future drug combinations."
Dr. Cohen-Dayag continued, "We are also encouraged by the promising rilvegostomig data presented by our partner, AstraZeneca, in 2024. Rilvegostomig is a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from COM902. AstraZeneca is running seven Phase 3 trials with rilvegostomig across lung and gastrointestinal cancers and plans to share early data for rilvegostomig in combination with their ADCs in 2025. AstraZeneca's broad development strategy for rilvegostomig to replace existing PD-1/PD-L1 inhibitors represents a significant potential revenue source for Compugen as we may be eligible for both future milestone payments and mid-single digit tiered royalties on future sales.
Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund our operations into 2027 allows us to advance our innovative clinical and early-stage pipeline. This includes advancing the Phase 1 trial of GS-0321, a potential first-in-class anti-IL18BP licensed to Gilead, for which we received a $30 million milestone payment for achieving IND clearance in 2024. Additionally, it enables us to continue to leverage our AI/ML powered predictive computational discovery platform, UnigenTM, to accelerate our research efforts supporting our early pipeline. Our Unigen platform is validated by our multiple potential first-in-class and potential best-in-class clinical programs, as well as our partnerships with AstraZeneca and Gilead."
Next Planned Milestones
Q2 2025 – initiation of a randomized adaptive platform trial comparing COM701 maintenance therapy to placebo in total of 60 patients with relapsed platinum sensitive ovarian cancer
2025 – Compugen's partner, AstraZeneca, plans to share early data for rilvegostomig in combination with their ADCs
H2 2026 – data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer
Fourth Quarter and Full Year 2024 Financial Highlights
Cash: As of December 31, 2024, Compugen had approximately $103.3 million in cash, cash equivalents, short-term bank deposits and investment in marketable securities. The cash balance at the end of 2024 includes the receipt of the upfront payment of $60 million from Gilead for the licensing of GS-0321, the $30 million milestone payment from Gilead for IND clearance (both subject to a 15% withholding tax) and the $15 million milestone payments from AstraZeneca on dosing of the first patient in the first and second major indications for rilvegostomig Phase 3 trials.
In January and February 2025, subsequent to the financial results for the year ended December 31, 2024, a total of approximately 3.96 million shares were sold through the Company's ATM facility contributing net proceeds of approximately $8.87 million (net of $274 thousand commission issuance expenses).
Compugen expects that its current cash will be sufficient to fund its operating plans into 2027. The Company has no debt.
Revenues: Compugen reported approximately $1.5 million in revenues for the fourth quarter of 2024 and $27.9 million in revenues for the year ended December 31, 2024, compared to approximately $33.5 million in revenues for each of the comparable periods in 2023. The revenues for 2024 include the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and the $5 million clinical milestone payment from AstraZeneca, while the revenues for 2023 reflect the portion of the upfront payment from the license agreement with Gilead allocated to the license and the previous clinical milestone from the license agreement with AstraZeneca in the amount of $10 million.
Cost of Revenues for the fourth quarter and year ended December 31, 2024, were approximately $0.7 million and $7.9 million, respectively, compared with approximately $2.0 million for both comparable periods in 2023. Cost of revenues for 2024 represents the cost of IND and Phase 1 activities and royalty payments in connection with Compugen's revenues, offset by royalty reversal in 2024 due to exemption received from the Israeli Innovation Authority from the requirement to pay royalties on income derived from sales associated with products related to IL-18BP, while cost of revenues for 2023 represents milestone and royalty payments in connection with our revenues.
R&D expenses for the fourth quarter and year ended December 31, 2024, decreased to approximately $5.9 million, and $24.8 million, respectively, compared with approximately $10.9 million and $34.5 million for the comparable periods in 2023, respectively. The decrease in 2024 was mainly due to the classification of expenses related to GS-0321 to cost of revenues and to lower CMC and IND enabling activities related to GS-0321, partially offset by an increase in clinical expenses.
G&A expenses for the fourth quarter and year ended December 31, 2024, were approximately $2.2 million and $9.4 million, respectively, compared with approximately $2.5 million and $9.7 million for the comparable periods in 2023, respectively.
Net Income / Loss: During the fourth quarter of 2024, Compugen reported a net loss of approximately $6.1 million, or approximately 7 cents per basic and diluted share, compared to a net income of approximately $9.7 million, or approximately 11 cents per basic and diluted share in the comparable period of 2023. Net loss for the year ended December 31, 2024, was approximately $14.2 million, or approximately 16 cents per basic and diluted share, compared with a net loss of approximately $18.8 million, or approximately 21 cents per basic and diluted share in the comparable period in 2023.
Full financial tables are included below.
Conference Call and Webcast Information
The Company will hold a conference call today, March 4, 2025, at 8:30 AM ET to review its fourth quarter and full year 2024 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website.
About Compugen
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (UnigenTM) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN.
Forward-Looking Statement To be updated
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statement regarding our expectations regarding the advancements of COM701 as a single agent and as a backbone to future drug combinations; statements regarding the initiation of a randomized adaptive platform trial comparing COM701 maintenance therapy to placebo in total of 60 patients with relapsed platinum sensitive ovarian cancer as well as the timing of any interim results from such sub-trial; statements regarding the timing of any data announcement by AstraZeneca regarding the combination of rilvegostomig with their ADCs; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2027; and statements that our cash position will enable us to continue to leverage our AI/ML powered predictive computational discovery platform, Unigen, to accelerate our research efforts supporting our early pipeline. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Company contact:
Yvonne Naughton, Ph.D.
Head of Investor Relations and Corporate Communications
Email: [email protected]
Tel: +1 (628) 241-0071
SOURCE Compugen Ltd.
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Phase 1License out/inPhase 3Financial StatementImmunotherapy
100 Deals associated with Rilvegostomig
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Phase 3 | United States | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | China | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Japan | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Brazil | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Canada | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Germany | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Hong Kong | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Spain | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Taiwan Province | 16 May 2025 | |
| Advanced Hepatocellular Carcinoma | Phase 3 | Vietnam | 16 May 2025 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 40 | Rilvegostomig 750 mg Q3W IV + XELOX (oxaliplatin + capecitabine) | trfthafsix(ouftmxqxyk) = nhjdavgcbh kmfbnrcrrd (atusjrahfl, 50.9 - 81.4) View more | Positive | 16 Sep 2024 | ||
Phase 1/2 | 96 | Rilvegostomig 750 mg (PD-L1 TPS 1-49%) | xqkjvohmxi(cjuameknti) = gfesabtoha gsotpctgwa (yrtmxfgwtq ) View more | Positive | 09 Sep 2024 | ||
Rilvegostomig 750 mg | xqkjvohmxi(cjuameknti) = fhnqvvlign gsotpctgwa (yrtmxfgwtq ) View more | ||||||
Phase 1/2 | Non-Small Cell Lung Cancer Second line | 83 | cunwughjsq(yvpvxhzozt) = iksafrhbfv cgrywpgyhe (mbmuzbheoi, 1.3 - 11.9) View more | Positive | 23 Oct 2023 | ||
Phase 1/2 | 80 | (overall) | wyxoyckcod(xhymscghev) = wjixwgxett grgbvpqioo (gbwmmifxnc ) View more | Positive | 26 May 2023 |
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