Latest news with #PDAC
Cision Canada
19 hours ago
- Business
- Cision Canada
Experimental Drug Development Centre Announces the Presentation of Updated Data from the Phase 1 Study of Antibody-Drug Conjugate EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO)
EBC-129 is an antibody-drug conjugate (ADC) that selectively targets a novel, tumour-specific N-glycosylated epitope found on both CEACAM5 and CEACAM6. The expansion cohort for pancreatic ductal adenocarcinoma (PDAC) in the ongoing Phase 1 trial has completed enrolment. Notably, 82% of patients had tumours expressing the antigen at levels considered treatable with EBC-129. EBC-129 demonstrated positive overall response rates and prolonged progression-free survival in PDAC patients that have been heavily pre-treated, including those that have received prior treatment with standard of care (SoC) typically containing taxanes. The US FDA also recently granted Fast Track Designation for EBC-129 in the treatment of PDAC patients. SINGAPORE, June 3, 2025 /CNW/ -- The Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development, has announced the presentation of updated clinical data for the ongoing Phase 1 trial for EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. The updated findings showed promising efficacy data from 21 heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patients across the dose escalation and the dose expansion portions of the Phase 1 study. Patients received EBC-129 at doses between 1.8 and 2.2 mg/kg, given once every 3 weeks. 17 out of 21 patients (81%) of the patients had received prior treatment with taxanes. 82% of patients had tumours which expressed the EBC-129 antigen at ≥1% at 3+ intensity and were therefore considered treatable. The overall response rates (ORRs) were 25% and 20%, with disease control rates (DCRs) of 87.5% and 63.6% and progression-free survival (PFS) of 19 and 12 weeks for 1.8 mg/kg and 2.2 mg/kg, respectively. "Pancreatic adenocarcinoma remains one of the most challenging cancers to treat, particularly in the metastatic setting where resistance to standard therapies is common. The clinical signals observed with EBC-129 in refractory pancreatic adenocarcinoma, including tolerability, prolonged disease control and a confirmed response in a heavily pre-treated patient, are encouraging and clinically meaningful. Continued prioritisation of biology-guided trials targeting EBC-129 will be key to sustaining momentum in this important therapeutic effort," said Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine. This presentation follows the recent Fast Track Designation granted by the U.S. FDA for EBC-129 in the treatment of PDAC patients. This designation supports EDDC's efforts to accelerate the advancement of the programme through increased regulatory engagement and the potential for expedited review pathways. Other Results to Date The dose escalation study of the Phase 1 trial was open to all patients, while the ongoing dose expansion study comprises of three cohorts in PDAC, gastroesophageal adenocarcinoma (GEA) and tumour-agnostic patients with other immunohistochemistry (IHC)-positive solid tumours. Recruitment for the GEA and IHC-positive cohorts is still ongoing. EBC-129 showed a manageable safety profile in the 58 patients treated so far, with uncomplicated neutropenia and infusion-related reactions as the main treatment-related adverse events (TRAEs) observed. The EBC-129 antigen was also found to be highly expressed, with 52% to 100% of tumour tissues assessed during the trial showing moderate to high expression levels of ≥20% at 2+ and/or 3+. This included samples from gastroesophageal, appendiceal, colorectal and lung cancer patients, making EBC-129 a potentially viable treatment option for these cancers. "We have seen encouraging signs of efficacy of EBC-129 as a single-agent therapy, even in heavily pre-treated patients with metastatic pancreatic cancer. This, combined with the observed safety profile, underscores the promise of EBC-129 as a possible treatment option for PDAC patients. As a first-in-class ADC that targets both CEACAM5 and CEACAM6, EBC-129 has also shown potential against a range of other solid tumours, and we look forward to expanding clinical evaluations with the ongoing dose expansion cohorts and accelerating the development of EBC-129 to address critical unmet needs in cancer," said Professor Damian O'Connell, CEO of EDDC. About EBC-129 EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay. The payload used in EBC-129 is monomethyl auristatin E (MMAE), which has been extensively tested and approved for clinical use in other marketed ADCs, and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours. Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts. About the Experimental Drug Development Centre The Experimental Drug Development Centre (EDDC) is Singapore's national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC) in 2019. EDDC aims to develop therapeutics and diagnostics that save and improve the lives of patients in Singapore, Asia and around the world. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works collaboratively with public sector and industry partners to translate the great science arising from Singapore's biomedical and clinical sciences R&D into innovative healthcare solutions. For more information about EDDC, please visit
Yahoo
a day ago
- Business
- Yahoo
Verastem Oncology Announces Updated Data from Partner GenFleet Therapeutics' Phase 1 Study in China of GFH375 (VS-7375), an Oral KRAS G12D (ON/OFF) Inhibitor
In the study in China, GFH375 demonstrated an ORR of 52% in patients with pancreatic ductal adenocarcinoma and an ORR of 42% with non-small cell lung cancer Company activating sites in the U.S. for VS-7375 to begin enrollment in the Phase 1/2a trial Company will host an R&D investor webcast on Monday, June 2, at 11:00 am CDT to review updated RAMP 205 data as well as updated data on GFH375 presented at the ASCO 2025 Annual Meeting BOSTON, June 02, 2025--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.). As of May 16, 2025, 23 efficacy-evaluable patients with pancreatic ductal adenocarcinoma (PDAC) and 12 efficacy-evaluable patients with non-small cell lung cancer (NSCLC) achieved an overall response rate (ORR) of 52% and 42%, respectively. The updated data were presented by Verastem's partner, GenFleet Therapeutics, in a rapid oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025, in Chicago, IL. "We are encouraged by the initial efficacy and safety results from the Phase 1 portion of the study of GFH375 in China by our partner, GenFleet Therapeutics. The results presented at ASCO further support our advancement of our clinical program for VS-7375 in the U.S., as we believe there remains a significant opportunity to further improve on the efficacy seen to date with other KRAS G12D-selective agents. VS-7375's dual inhibition of both the ON/OFF states has the potential to drive deep and durable cancer responses and allow for better combinability with other agents," said Dan Paterson, president and chief executive officer of Verastem Oncology. ASCO 2025 Presentation Highlights GenFleet reported that 62 patients were enrolled in the Phase 1 portion of the study in China, receiving oral doses ranging from 100 to 900 mg daily. In the study, 98% of patients had metastatic disease, and 75% had received ≥2 prior lines of therapy. As of the data cutoff of May 16, 2025, 23 efficacy-evaluable patients with PDAC and 12 efficacy-evaluable patients with NSCLC, who received daily dosages of 400 or 600 mg and had at least one post-treatment tumor assessment, achieved an ORR of 52% and a disease control rate (DCR) of 100%, and an ORR of 42% and a DCR of 83%, respectively. As of the cutoff date of March 31, 2025, GenFleet reported that there were no dose-limiting toxicities (DLTs) observed across all dose levels (100-900 mg QD), and the treatment-related adverse events (TRAEs) were mostly Grade 1/2. The most common TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia. TRAEs ≥ Grade 3 consisted mainly of decreased neutrophil count (8%) and diarrhea (5%). No TRAE-related deaths were reported. Webcast Information Verastem will hold an investor webcast on Monday, June 2, at 11:00 am CDT, to review the RAMP 205 updated data and the VS-7375 program including updated data from the study in China. The event will feature members of Verastem's management team and key opinion leaders. A live audio webcast of the call, along with accompanying slides, will be accessible here. A replay of the webcast will be archived on the website for approximately 90 days following the presentation. U.S. Phase 1/2a Study of VS-7375 The Phase 1/2a study will be conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study of 400 mg is based on the dose identified in the initial data from the GenFleet study to accelerate the trial's progress. Verastem plans to dose escalate across levels where responses were observed in GenFleet's study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers. About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and plans to initiate a Phase 1/2a clinical trial in mid-2025. GenFleet's IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024. About the GenFleet Therapeutics Collaboration The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. These licenses give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit and follow us on LinkedIn. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology's programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the expected outcome and benefits of the Company's collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company's clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; the risk that our preliminary and interim data may not be representative of more mature data; uncertainties related to the recent change in the U.S. presidential administration, including regulatory and policy changes that may adversely affect our business; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC) on March 20, 2025, as well as the other information we file with the SEC, are possibly realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. View source version on Contacts For Investor and Media Inquiries: Julissa VianaVice President, Corporate Communications,Investor Relations & Patient Advocacyinvestors@ ormedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
a day ago
- Business
- Business Wire
Verastem Oncology Announces Updated Data from Partner GenFleet Therapeutics' Phase 1 Study in China of GFH375 (VS-7375), an Oral KRAS G12D (ON/OFF) Inhibitor
BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.). As of May 16, 2025, 23 efficacy-evaluable patients with pancreatic ductal adenocarcinoma (PDAC) and 12 efficacy-evaluable patients with non-small cell lung cancer (NSCLC) achieved an overall response rate (ORR) of 52% and 42%, respectively. The updated data were presented by Verastem's partner, GenFleet Therapeutics, in a rapid oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025, in Chicago, IL. 'We are encouraged by the initial efficacy and safety results from the Phase 1 portion of the study of GFH375 in China by our partner, GenFleet Therapeutics. The results presented at ASCO further support our advancement of our clinical program for VS-7375 in the U.S., as we believe there remains a significant opportunity to further improve on the efficacy seen to date with other KRAS G12D-selective agents. VS-7375's dual inhibition of both the ON/OFF states has the potential to drive deep and durable cancer responses and allow for better combinability with other agents,' said Dan Paterson, president and chief executive officer of Verastem Oncology. ASCO 2025 Presentation Highlights GenFleet reported that 62 patients were enrolled in the Phase 1 portion of the study in China, receiving oral doses ranging from 100 to 900 mg daily. In the study, 98% of patients had metastatic disease, and 75% had received ≥2 prior lines of therapy. As of the data cutoff of May 16, 2025, 23 efficacy-evaluable patients with PDAC and 12 efficacy-evaluable patients with NSCLC, who received daily dosages of 400 or 600 mg and had at least one post-treatment tumor assessment, achieved an ORR of 52% and a disease control rate (DCR) of 100%, and an ORR of 42% and a DCR of 83%, respectively. As of the cutoff date of March 31, 2025, GenFleet reported that there were no dose-limiting toxicities (DLTs) observed across all dose levels (100-900 mg QD), and the treatment-related adverse events (TRAEs) were mostly Grade 1/2. The most common TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia. TRAEs ≥ Grade 3 consisted mainly of decreased neutrophil count (8%) and diarrhea (5%). No TRAE-related deaths were reported. Webcast Information Verastem will hold an investor webcast on Monday, June 2, at 11:00 am CDT, to review the RAMP 205 updated data and the VS-7375 program including updated data from the study in China. The event will feature members of Verastem's management team and key opinion leaders. A live audio webcast of the call, along with accompanying slides, will be accessible here. A replay of the webcast will be archived on the website for approximately 90 days following the presentation. U.S. Phase 1/2a Study of VS-7375 The Phase 1/2a study will be conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study of 400 mg is based on the dose identified in the initial data from the GenFleet study to accelerate the trial's progress. Verastem plans to dose escalate across levels where responses were observed in GenFleet's study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers. About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and plans to initiate a Phase 1/2a clinical trial in mid-2025. GenFleet's IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024. About the GenFleet Therapeutics Collaboration The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. These licenses give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit and follow us on LinkedIn. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as 'anticipate,' 'expect,' 'plan,' 'could,' 'may,' 'believe,' 'estimate,' 'forecast,' 'goal,' 'project,' and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology's programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the expected outcome and benefits of the Company's collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company's clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; the risk that our preliminary and interim data may not be representative of more mature data; uncertainties related to the recent change in the U.S. presidential administration, including regulatory and policy changes that may adversely affect our business; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC) on March 20, 2025, as well as the other information we file with the SEC, are possibly realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Medscape
2 days ago
- Health
- Medscape
In Pancreatic Cancer, Does New PAXG Beat Out mFOLFIRINOX?
CHICAGO — For patients with pancreatic resectable stage I-Ill pancreatic ductal adenocarcinoma (PDAC), neoadjuvant chemotherapy can help improve overall survival compared with upfront surgery. But what chemotherapy regimen provides the best survival outcomes? Findings from the phase 3 CASSANDRA PACT-21 trial, presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, revealed that a newer regimen — PAXG chemotherapy — significantly prolonged event-free survival compared with standard-of-care chemotherapy with mFOLFIRINOX. Although immature, the overall survival data suggest that PAXG — capecitabine, cisplatin, nab-paclitaxel, and gemcitabine — may beat out mFOLFIRINOX — oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil. PAXG also led to a significant improvement in key secondary outcomes, including the disease control rate, pathological stage, and detection of intraoperative or early postoperative metastases. Should these findings change practice? PAXG appears to be the 'most suitable option' for neoadjuvant treatment of these patients, reported Michele Reni, MD, with the Department of Medical Oncology, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy, who presented the findings at ASCO. However, study discussant Brian Wolpin, MD, MPH, is not yet ready to call PAXG the new standard of care. While preoperative PAXG is a 'very promising approach with the potential to change standard of care, more follow-up is needed, particularly overall survival data, to decide whether it should change our standard of care,' said Wolpin, chair of pancreatic cancer at Dana-Farber Cancer Institute in Boston, Massachusetts. In other words, the data are 'not quite sufficient' at this point to change standard of care, Wolpin said. The CASSANDRA PACT-21 trial enrolled 261 patients aged 75 and younger with treatment-naive stage I-III resectable or borderline resectable PDAC and a Karnofsky performance status (KPS) greater than 60%. After CA19-9 stratification, 133 were randomly allocated to PAXG and 128 to mFOLFIRINOX administered every 14 days for 4 months. After this, a second randomization was performed, with patients assigned to receive either 2 additional months of the same chemotherapy regimen followed by surgery, or surgery followed by the same chemotherapy. The primary endpoint was event-free survival, defined as absence of progression, recurrence, two consecutive CA19-9 increases ≥ 20% separated by at least 4 weeks, unresectability, intraoperative metastasis, or death. Median follow-up was 24.5 months in the PAXG group and 26 months in the mFOLFIRINOX group. In the final analysis, with 179 events, median event-free survival was 16 months with PAXG vs 10 months with mFOLFIRINOX. The 3-year event-free survival rate was 31% with PAXG vs 13% with mFOLFIRINOX (hazard ratio [HR], 0.64; P = .003). Subgroup analyses showed a doubling of 3-year event-free survival with PAXG over mFOLFIRINOX in the resectable group (41% vs 22%) and borderline resectable group (19% vs 9%), Reni noted. Reni said the overall survival data are immature, but favor PAXG over mFOLFIRINOX, with median overall survival of 37 months vs 26 months and a 3-year overall survival rate of 51% vs 40% (HR, 0.70; P = .07). Regarding key secondary endpoints, PAXG significantly improved the disease control rate (98% vs 91%), CA19-9 response ≥ 50% rate (88% vs 64%), pathological complete response rate (3% vs 0%), N0 resection rate (36% vs 23%), and detection of intra- or postoperative metastases (5% vs 12%). The secondary endpoints 'add some additional evidence' suggesting that PAXG may be an effective regimen compared to mFOLFIRINOX, Wolpin told ASCO attendees. In terms of adverse events, no statistically significant difference was detected, except for a higher rate of grade 3-4 neutropenia in the PAXG group (42% vs 29%), Reni reported. There was a trend toward worse score in nausea/vomiting scale in the mFOLFIRINOX group at 4 months compared with baseline. At 4 months, both groups had clinically meaningful deterioration in fatigue, taste, weight loss concern, and hepatic symptoms. In his discussion, Wolpin noted that even though PAXG looks like it may be a more effective therapy in preventing recurrence, the event-free survival rate was still only 31% at 3 years. "This really shows that we may hit a plateau with what we can do with chemotherapy and surgery, and there has to be some additional thought and implementation of biologically driven therapies,' he explained. Looking to the future, 'I eagerly await further survival data from the CASSANDRA trial," alongside other relevant trial data from PREOPANC-3 and ALLIANCE A021806, to "help define the appropriate therapy for these patients," Wolpin said.
Yahoo
4 days ago
- Business
- Yahoo
Why Is Nano-Cap BioLineRx Stock Surging On Friday?
BioLineRx Ltd's (NASDAQ:BLRX) poster, which includes new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination trial, will be presented at the 2025 American Society of Clinical Oncology Annual Meeting. The CheMo4METPANC trial is evaluating motixafortide, cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC). Updated results from the pilot phase indicate that four of eleven patients remained progression-free after more than one patients underwent definitive treatment for mPDAC: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre-and-on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. In addition, patients achieving a partial response were found to have higher pre-treatment proportions of CXCL12-producing cancer-associated fibroblasts, a potential marker of response. The pilot clinical trial of motixafortide, cemiplimab, gemcitabine and nab-paclitaxel (N=11) demonstrated an overall response rate (ORR) of 64% (7/11) and a disease control rate (DCR) of 91% (10/11), compared to historical ORR and DCR of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel. Based on these results, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. The trial will be fully enrolled in 2027, and a prespecified interim analysis is planned for when 40% of PFS events are observed. Earlier this week, BioLineRx said it reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the company's U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions. The company completed financing in January 2025, raising gross proceeds of $10 million and reaffirmed cash runway through the second half of 2026. Jones Trading upgraded BioLine Rx from Hold to Buy and announced a $12 price target. Price Action: BLRX stock is up 42.7% at $5.41 at the last check on Friday. Read Next:Photo by jittawit21 via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? BIOLINE RX (BLRX): Free Stock Analysis Report This article Why Is Nano-Cap BioLineRx Stock Surging On Friday? originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
