TKI

Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib

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Sabato, Giugno 1, 2024
MD, Cullinan, Patient, NSCLC, Society, MBA, Therapy, Amivantamab, EGFR, Doctor of Philosophy, FACP, TKI, Partnership

“With a comprehensive development plan for zipalertinib, this data further strengthens our confidence in its potential to address a significant unmet need for patients with NSCLC harboring EGFR exon20 insertion mutations.

Key Points: 
  • “With a comprehensive development plan for zipalertinib, this data further strengthens our confidence in its potential to address a significant unmet need for patients with NSCLC harboring EGFR exon20 insertion mutations.
  • Both Module B2 (post chemo only) and Module C (post approved ex20ins treatments) of the pivotal REZILIENT1 trial remain on track to complete enrollment by end of 2024, consistent with prior projections.
  • Cullinan Therapeutics will host an Investor Event on Saturday, June 1, 2024, at 6:30 PM Central Time, during which Dr. Jeff Jones, Chief Medical Officer at Cullinan Therapeutics, will present an overview of this zipalertinib data along with CLN-619 data shared at the 2024 American Society of Clinical Oncology Annual Meeting.
  • Investors and analysts are invited to register to attend in person by emailing Chad Messer, VP Investor Relations ( [email protected] ).

Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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Sabato, Giugno 1, 2024
Diamond, GBM, ASCO, Temozolomide, IC50, Patient, Fatigue, AACR, HGG, Diarrhea, Annual general meeting, Cancer, Safety, Glioblastoma, Stomatitis, Society, Pharmacokinetics, Dana–Farber Cancer Institute, Paronychia, EGFR, Diagnosis, PD, Lung cancer, Rash, Brain, TKI, Recurrence, Nausea, Conference, Medical imaging

CAMBRIDGE, Mass., June 01, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today presented additional data from the Phase 1 dose escalation trial of BDTX-1535 in patients with recurrent glioblastoma (GBM), and initial data from a phase 0/1 “trigger” (“window of opportunity”) investigator-sponsored trial at the American Society of Clinical Oncology (ASCO) Annual Meeting. Clinical data from these trials in patients with recurrent GBM demonstrated brain penetrance of BDTX-1535, as well as safety and tolerability data similar to what has been previously described for patients with non-small cell lung cancer (NSCLC). In addition, the Phase 1 trial demonstrated encouraging anti-tumor activity and duration of treatment for patients with previously treated GBM.

Key Points: 
  • In addition, the Phase 1 trial demonstrated encouraging anti-tumor activity and duration of treatment for patients with previously treated GBM.
  • Patients received increasing doses of BDTX-1535 in 21-day cycles to assess safety/tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity.
  • Five patients remained on BDTX-1535 treatment for ≥4 months, 1 patient for ≥6 months, and 3 patients for ≥10 months.
  • Patients achieving the PK threshold were enrolled in the post-resection component of the study with an update expected in the fourth quarter of 2024.

Obsidian Therapeutics Announces Additional OBX-115 Safety and Efficacy Data in Oral Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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Lunedì, Giugno 3, 2024
Oncology, Health, Health Technology, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Safety, ASCO, IL15, Patient, Melanoma, University, Cell, Annual general meeting, NSCLC, MD Anderson Cancer Center, Society, Therapy, PR, Capillary leak syndrome, PFS, Cytokine release syndrome, TIL, Disease, Progression-free survival, IL2, Lung cancer, TKI, ICI, Pharmaceutical industry

These data were presented in an oral presentation delivered by Rodabe Amaria, M.D.

Key Points: 
  • These data were presented in an oral presentation delivered by Rodabe Amaria, M.D.
  • , professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • The oral presentation for the single-center study ( NCT05470283 ) included a 3-month incremental data update (relative to published abstract) on safety (N=10) and efficacy (n=9 per-protocol efficacy analysis set) for patients with advanced or metastatic melanoma.
  • Summary of OBX-115 Safety and Efficacy Data (April 4, 2024 data cutoff):
    OBX-115 Exhibits Positively Differentiated Safety Profile Relative to IL2-Dependent Non-Engineered TIL Cell Therapy:
    No patient received care in the intensive care unit.

Ivonescimab Manuscript for HARMONi-A Clinical Trial Results Published in JAMA

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Sabato, Giugno 1, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, PD-1, ASCO, Webcast, SMMT, JAMA, Manuscript, Summit, HKEX, Patient, NSCLC, Therapy, American Medical Association, EGFR, Journal, TKI, Conference

This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.

Key Points: 
  • This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.
  • The Phase III HARMONi-A study provides further evidence supporting the differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics.
  • Summit Therapeutics Inc. will host a conference call to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday, June 3, 2024, before the market opens.
  • An archived edition of the webcast will be available on our website later in the day on Monday.

Nuvation Bio Announces Data from Pivotal Phase 2 TRUST-I Study of its Investigational ROS1 Inhibitor, Taletrectinib, are Published in the Journal of Clinical Oncology and Reported at 2024 ASCO Annual Meeting

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Sabato, Giugno 1, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Safety, ASCO, Crizotinib, Vomiting, Diarrhea, Annual general meeting, NSCLC, NUVB, JCO, Society, Metastasis, Incidence, Professor, PFS, Corr, Disease, Journal, Dizziness, Abstract, Brain tumor, IRC, ROS1, Progression-free survival, Brain, Neoplasm, TKI, Anemia, Shanghai East Hospital, Phase, Tongji University, Pharmaceutical industry

Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib.

Key Points: 
  • Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib.
  • After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached.
  • After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively.
  • Taletrectinib’s safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events (TEAEs).

IDRx Reports Updated Preliminary Phase 1 Data from Ongoing Phase 1/1b StrateGIST 1 Trial Supporting Best-in-Class Potential for IDRX-42 in Patients with GIST

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Lunedì, Giugno 3, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ASCO, RECIST, Vomiting, Patient, Fatigue, Mutation, Diarrhea, Strategist, Annual general meeting, KIT, Data, Exon, Safety, Hypertension, Society, UZ Leuven, Appetite, DNA, Circulating tumor DNA, Infrared spectroscopy correlation table, First grade, Death, TKI, Dysgeusia, BID, Neoplasm, GIST, PRS, Nausea, Pharmaceutical industry

These data will be highlighted today in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • These data will be highlighted today in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • “There is a significant unmet medical need for next-generation therapies for GIST patients.
  • 74% of patients remained on study treatment, and the median duration of treatment was 16 weeks as of the data cut-off.
  • “In this dataset, IDRx has presented preliminary proof-of-concept of IDRX-42 supporting its potentially best-in-class profile in patients with GIST,” said Tim Clackson, Ph.D., Chief Executive Officer of IDRx.

Elevar Therapeutics Reports Landmark Median Overall Survival of 23.8 Months in First-Line Treatment for Unresectable Hepatocellular Carcinoma

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Giovedì, Maggio 30, 2024
Patient, Progression-free survival, TKI, Survival, MD Anderson Cancer Center, University, PLR, Therapy, PFS, NLR, ASCO, Division, OS, Society, Hepatocellular carcinoma, Immunotherapy, Camrelizumab, Sorafenib, Annual general meeting, Pharmaceutical industry

“The CARES-310 final OS analysis confirmed statistically superior and clinically meaningful survival improvement with a manageable safety profile for the combination of camrelizumab and rivoceranib as a first-line treatment for patients suffering from unresectable hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.

Key Points: 
  • “The CARES-310 final OS analysis confirmed statistically superior and clinically meaningful survival improvement with a manageable safety profile for the combination of camrelizumab and rivoceranib as a first-line treatment for patients suffering from unresectable hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.
  • For the final analysis, 16 months later, camrelizumab + rivoceranib continued to show clinically meaningful survival improvement compared with sorafenib, with manageable safety profile.
  • The extended follow-up further confirmed the favorable benefit-to-risk profile of camrelizumab + rivoceranib, supporting it as a potential new first-line treatment option for uHCC.
  • CARES-310 was the first trial to demonstrate significant progression-free survival (PFS) and overall survival benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as first-line treatment for uHCC.

 Ivonescimab in Combination with Chemotherapy Approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A Clinical Trial: Positive Trend Observed in Overall Survival towards Ivonescimab Plus Chemotherapy

Retrieved on: 
Sabato, Giugno 1, 2024
Science, Radiology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, SMMT, National Medical Products Administration, Patient, HKEX, TKI, Data, NMPA, PFS, EGFR, NSCLC, Neoplasm, PD-1

This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.

Key Points: 
  • This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.
  • Median PFS for ivonescimab plus chemotherapy was 7.1 months (95% CI: 5.9 – 8.7), as compared to 4.8 months (95% CI: 4.2 – 5.6) for placebo plus chemotherapy.
  • Both overall survival curves appear to demonstrate clear separation between the two arms of the trial and show a trend in improvement of survival towards ivonescimab plus chemotherapy.
  • Overall response rate (ORR) was 50.6% (95% CI: 42.6% – 58.6%) for those receiving ivonescimab plus chemotherapy vs. 35.4% (95% CI: 28.0% - 43.3%) for those receiving chemotherapy alone.

Merus Announces Publication of Abstracts for Presentation at the 2024 ASCO® Annual Meeting

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Giovedì, Maggio 23, 2024
Patient, TKI, Pembrolizumab, Glioblastoma, Lung cancer, Non-small-cell lung cancer, Safety, EGFR, NSCLC, RECIST, PRS, Stomach, Cancer, Sarcoma, Abstract, Society, Immunotherapy, PD-L1, CD137, Annual general meeting

UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced the publication of an abstract regarding MCLA-145 and an abstract regarding MCLA-129 at the 2024 American Society of Clinical Oncology® (ASCO®) Annual Meeting taking place in Chicago May 31-June 4, 2024. Both abstracts can be found on the 2024 ASCO® website.

Key Points: 
  • Both abstracts can be found on the 2024 ASCO® website.
  • “We continue to be proud of our Multiclonics® technology platforms' ability to develop bispecific antibodies for clinical investigation with the potential to impact patients’ lives,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus.
  • Pts treated with the combination of MCLA-145 and pembrolizumab had cancers that either relapsed after PD-(L)1 therapies or were immunotherapy naïve.
  • Poster presentation title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-MET exon 14 skipping mutations (METex14)
    As full presentations become available at the 2024 ASCO® Annual Meeting, they will contemporaneously be available on the Merus website .

Xspray to present data at ASCO highlighting frequent comedication of PPIs with TKIs in CML-patients and greater than expected negative effects on the bioavailability of crystalline dasatinib

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Giovedì, Maggio 23, 2024
Oncology, Health, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, Proton, Acute leukemia, Patient, TKI, PPI, Prescription, CML, Karolinska Institute, Proton-pump inhibitor, Cmax, Enzyme inhibitor, Teaching hospital, Effect, Absorption, Tablet, Chronic myelogenous leukemia, Omeprazole, Combination therapy, Cancer, ASCO, Uppsala University, Society, NT, Dasatinib, Annual general meeting, Pharmaceutical industry

Of those prescribed a PPI, 66% of the prescriptions were by a different healthcare provider.

Key Points: 
  • Of those prescribed a PPI, 66% of the prescriptions were by a different healthcare provider.
  • Further, the presentation provides new information on the bioavailability of crystalline dasatinib when comedicated with a PPI, demonstrating a substantially higher than previously reported impact of PPIs on the bioavailability of crystalline dasatinib, with Cmax and AUC24 being reduced by 96% and 88% respectively.
  • “Consistent absorption and bioavailability of dasatinib are critical for adequate disease control and patient outcomes, this is however often overlooked in clinical practice as our data demonstrates,” said Per Andersson, CEO of Xspray.
  • Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability.