Cholangiocarcinoma

Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, August 8, 2023

SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the second quarter 2023 along with recent pipeline and corporate updates.

Key Points: 
  • ET / 2:30 p.m. PT
    SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the second quarter 2023 along with recent pipeline and corporate updates.
  • Based on these results, the Company plans to discuss a tumor agnostic Accelerated Approval approach with FDA by year-end 2023.
  • Net reduction in cash, cash equivalents and short-term investments for the second quarter of 2023 was $122.9 million.
  • ET / 2:30 p.m. PT during which company executives will review financial information for the second quarter and provide corporate updates.

Sojitz Signs Memorandum of Understanding for Strategic Alliance with HIROTSU Bioscience, WHO Foundation, OurCrowd and Global Health Equity Fund

Retrieved on: 
Thursday, June 15, 2023

N-NOSE® is a simple, inexpensive, highly accurate, and comprehensive systemic cancer screening test that can be used to detect early-stage cancer simply by submitting urine.

Key Points: 
  • N-NOSE® is a simple, inexpensive, highly accurate, and comprehensive systemic cancer screening test that can be used to detect early-stage cancer simply by submitting urine.
  • Sojitz and HIROTSU concluded a capital and business alliance agreement in February 2022 and have been promoting the international development of N-NOSE® under a mutual cooperation.
  • GHEF is a unique financial-first impact venture capital investment fund, focusing on breakthrough technology solutions that can impact healthcare globally.
  • Launched by OurCrowd and the WHO Foundation, GHEF aims for impact on health equity.

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer

Retrieved on: 
Thursday, June 8, 2023

The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.

Key Points: 
  • The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.
  • Results from KEYNOTE-966 were presented at the American Association for Cancer Research (AACR) 2023 Annual Meeting.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of February 7, 2024.
  • “Most biliary tract cancers go undetected until an advanced stage, at which point many patients are ineligible for surgery and have few treatment options,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories.

Repare Therapeutics Reports Proof of Concept for Lunresertib (RP-6306) in Clinic, Initial Monotherapy Data from Phase 1 MYTHIC Clinical Trial and Early Insights from Ongoing Combination Trials

Retrieved on: 
Wednesday, June 7, 2023

“The data demonstrate that lunresertib effectively inhibits PKMYT1 and offers a synthetic lethal combination with CCNE1 amplification or inactivating mutations in FBXW7 and PPP2R1a.

Key Points: 
  • “The data demonstrate that lunresertib effectively inhibits PKMYT1 and offers a synthetic lethal combination with CCNE1 amplification or inactivating mutations in FBXW7 and PPP2R1a.
  • As of the data cutoff date of April 28, 2023, 63 patients were enrolled in lunresertib monotherapy Module 1 of the MYTHIC study, which is ongoing and accruing patients.
  • Early clinical combination insights demonstrated greater anti-tumor activity in patients treated with the combination of lunresertib and camonsertib than lunresertib alone, based on higher molecular response rates and RECIST 1.1 responses.
  • Repare is also currently evaluating lunresertib in combination with gemcitabine in the Phase 1 MAGNETIC study and in combination with FOLFIRI in the Phase 1 MINOTAUR study.

Burning Rock Reports First Quarter 2023 Financial Results

Retrieved on: 
Tuesday, May 30, 2023

GUANGZHOU, China, May 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended March 31, 2023.

Key Points: 
  • GUANGZHOU, China, May 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended March 31, 2023.
  • Results of the MEDAL (MEthylation Based Dynamic Analysis for Lung Cancer) study were published at the American Association for Cancer Research Annual Meeting 2023 (“AACR 2023”).
  • The results of the clinical performance of brPROPHET™ in patients with resectable gastric cancer and biliary tract cancer were also released at AACR 2023.
  • Burning Rock will host a conference call to discuss the first quarter 2023 financial results at 8:00 a.m. U.S. Eastern Time (8:00 p.m. Hong Kong time) on May 30, 2023.

New Natera Data to be Presented at the 2023 ASCO Annual Meeting in 13 Studies Across Multiple Cancer Types

Retrieved on: 
Tuesday, May 30, 2023

“We are grateful for the opportunity to share new data at ASCO that furthers Natera’s leadership in the ctDNA space,” said Minetta Liu, M.D., chief medical officer of oncology at Natera.

Key Points: 
  • “We are grateful for the opportunity to share new data at ASCO that furthers Natera’s leadership in the ctDNA space,” said Minetta Liu, M.D., chief medical officer of oncology at Natera.
  • “These presentations provide additional support for the role of ctDNA in predicting patient outcomes and assessing treatment response in both common and rare cancers.
  • Use of data generated from our ctDNA technology to broaden our understanding of tumor biology is also demonstrated.
  • Also, in patients with ctDNA negativity at 4 weeks, no significant difference in DFS was observed between BRAF V600E mutant and wild-type groups (p=0.306).

Mirati To Encore Compelling Clinical Data Demonstrating Adagrasib's Potential as a Targeted Treatment for KRASG12C-Mutated Advanced Solid Tumors at 2023 ASCO Annual Meeting

Retrieved on: 
Tuesday, May 30, 2023

SAN DIEGO, May 30, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.®  (NASDAQ: MRTX), a commercial stage biotechnology company, today announced presentations and posters to be shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the utility of adagrasib across multiple tumor types.

Key Points: 
  • Phase 2 data from the KRYSTAL-1 study demonstrates the potential value of adagrasib monotherapy for patients with unresectable or metastatic KRASG12C-mutated solid tumors beyond non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
  • In addition, the company announced that it will present two posters which highlight real-world observations in patients living with metastatic NSCLC (mNSCLC).
  • Real-world study of treatment patterns and clinical outcomes in patients with mNSCLC post-approval of immunotherapy in the community oncology setting: Saturday, June 3, 2023 at 11:15 a.m. – 2:15 p.m. PT / 2:15-5:15 p.m.
  • ET (Abstract 6629) during the Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Session.

HUTCHMED Highlights Presentations at the 2023 ASCO Annual Meeting

Retrieved on: 
Thursday, May 25, 2023

13 presentations and publications, including several investigator-initiated-trials (“IITs”), are listed in the table below.

Key Points: 
  • 13 presentations and publications, including several investigator-initiated-trials (“IITs”), are listed in the table below.
  • These new analyses add to the understanding of fruquintinib efficacy by specific lines of therapy as well as adverse events of special interest (“AESI”).
  • Median PFS was not reached when results from this study were initially presented at the 2021 Chinese Society of Clinical Oncology Annual Meeting (data cut-off on August 31, 2021).
  • Preclinical data presented at the American Association for Cancer Research Annual Meeting 2023 (AACR 2023) showed that it has strong activity against FGFR-deregulated tumors, supporting investigation in patients with FGFR alterations (such as fusion and mutation) either as a single agent or in combination with PD-1 blockade.

Servier Targets Transformative Treatment of Cancer at ASCO 2023

Retrieved on: 
Thursday, May 25, 2023

BOSTON and PARIS, May 25, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will showcase new data across its robust oncology portfolio at the American Society of Clinical Oncology (ASCO) annual meeting June 2-6, 2023. These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.

Key Points: 
  • These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.
  • Among the data to be presented is a late breaking abstract featuring the results from the Phase 3 INDIGO study of vorasidenib in patients with residual or recurrent grade 2 IDH-mutant glioma.
  • "Servier is leading the scientific research with IDH inhibition across a variety of difficult to treat cancers, and this year at ASCO, we are excited to showcase data that has the potential to shift the treatment paradigm for patients with IDH-mutant glioma," said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier.
  • Servier abstracts being presented at EHA are listed below (all times in Central European Summer Time) and are available online on the EHA website here .

Aravive Reports First Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, May 10, 2023

If successful, the Company plans to submit a BLA by year-end 2023.

Key Points: 
  • If successful, the Company plans to submit a BLA by year-end 2023.
  • In March 2023, preclinical results from a study of batiraxcept in bile duct cancer were published in the peer-reviewed journal Cancers.
  • As of March 31, 2023, cash and cash equivalents were $35.9 million, compared to $53.7 million as of December 31, 2022.
  • The Company anticipates that its current cash and cash equivalents will fund operating plans into the fourth quarter of 2023.