Safety Review Committee Approval to Advance to Ph 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA + Tagrisso in Advanced NSCLC
“We are proud of the notable progress we made during the Phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the Phase 2 expansion portion of the trial is another validation for our REQORSA development program,” said Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. “As we […]
KEYTRUDA + Chemo Before Surgery and Continued as a Single Agent After Surgery Reduced the Risk of Event-Free Survival Events by 42% Versus Pre-Operative Chemotherapy in Resectable Stage II, IIIA or IIIB NSCLC
“Historically, more than half of people with earlier stages of non-small cell lung cancer that has been surgically removed will experience recurrence,” said Dr. Heather Wakelee, thoracic medical oncologist and professor of medicine at Stanford Medicine, president of the International Association for the Study of Lung Cancer and principal investigator for KEYNOTE-671. “Results showed that […]
KEYTRUDA + Chemo Significantly Improved OS Versus Chemo Alone as First-Line Treatment for Unresectable Advanced Pleural Mesothelioma
“Patients with pleural mesothelioma are usually diagnosed at an advanced stage, when the five year survival rate is only 12% and curative surgery is not an option,” said Dr. Lesley Seymour, Director of the Investigational New Drug program at CCTG, and Senior Investigator for IND.227. “The addition of pembrolizumab to platinum-pemetrexed in our study resulted […]
New FIREFLY-1 Data Announced for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma
“We believe the data presented at ASCO for monotherapy tovorafenib demonstrate durable responses in children with relapsed pLGG who have limited treatment options,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Based on the strength of the safety and efficacy data we’ve observed to date, we believe tovorafenib has a compelling clinical profile. […]
Domvanalimab Continues To Demonstrate Consistent Improvement In PFS In NSCLC Study
“Progression-free survival curves showed early separation of both domvanalimab-containing arms from the zimberelimab arm, which was consistently maintained, and supports the potential therapeutic benefit of inhibiting the TIGIT pathway,” said Melissa L. Johnson, M.D., Director, Lung Cancer Research, Sarah Cannon Research Institute, and Lead Investigator for the ARC-7 study. “I was also encouraged by the […]
First-Ever Results from Dual Bispecific Combination Study Showing 96% ORR in Patients with Relapsed or Refractory Multiple Myeloma
“By combining teclistamab and talquetamab, two bispecific antibodies that have demonstrated high efficacy responses in targeting distinct antigens, we evaluated the potential of this unique combination regimen for patients who were resistant or refractory to multiple lines of therapy,” said Yael Cohen, M.D., Head of Myeloma Unit, Hematology Institute, Tel-Aviv Sourasky Medical Center, Israel, and […]
Longer-Term Talquetamab Follow-Up Data Showing ORR of More Than 70% in Heavily Pretreated Patients with Multiple Myeloma presented
“The updated results from the MonumenTAL-1 study continue to show the encouraging potential of talquetamab for heavily pretreated patients with multiple myeloma, including those who may have been exposed to prior T-cell redirection therapy,” said Carolina Schinke, M.D., Associate Professor of Medicine at the Myeloma Center at the University of Arkansas for Medical Sciences and […]
New Long-Term Data from the CHRYSALIS Study Show mPFS Not Reached after 33.6 Months of Follow-Up with 1L RYBREVANT and Lazertinib Combination Therapy in Patients with Treatment-Naïve EGFR-Mutated Advanced NSCLC
“Advanced NSCLC and EGFR-mutated lung cancer has a five-year survival rate of less than 20 percent, underscoring an urgent need for more targeted treatment options, especially in earlier lines of therapy,” said Se-Hoon Lee**, M.D., Ph.D., professor of medicine at the Samsung Medical Center and Sungkyunkwan University School of Medicine, and presenting author. “These long-term […]
Four-Year Outcomes from Ph 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo + Yervoy with 2 Cycles of Chemotherapy for mNSCLC Patients
“The durable results seen with nivolumab plus ipilimumab with chemotherapy over four years, especially in patients typically facing a poor prognosis, demonstrate the sustained benefits of combining dual immunotherapy with limited chemotherapy for patients with advanced or metastatic non-small cell lung cancer, which remains an incredibly challenging disease to treat,” said David P. Carbone, M.D., […]
Tagrisso achieved unprecedented survival in early-stage EGFR-mutated lung cancer, with 88% of patients alive at five years in ADAURA Ph 3 trial
Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut, US, and principal investigator in the trial, said: “These highly anticipated overall survival results, with 88 per cent of patients alive at five years, are a momentous achievement in the treatment of […]
IMFINZI + chemo significantly improved pathologic complete response in gastric and gastroesophageal junction cancers in MATTERHORN Ph 3 trial
Josep Tabernero, MD, PhD, head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain, and principal investigator of the MATTERHORN trial, said: “Patients with resectable gastric and gastroesophageal junction cancers urgently need better treatment options, because today, one in four patients still progress within one year even after surgery with curative intent. These […]
FDA Accepts for Priority Review Repotrectinib’s Application for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive NSCLC
“Patients with ROS1-positive non-small cell lung cancer face a rare disease with a significant unmet medical need given the limited durability of benefit and emergence of resistance to approved therapies,” said Jonathan Cheng, M.D., senior vice president and head of oncology development, Bristol Myers Squibb. “The FDA’s acceptance of this application marks an exciting milestone […]
Strategic Update provided on AFM24 Development Plan
“We believe that AFM24 can be an important addition to the treatment armamentarium for addressing EGFR mutant tumors as the early anti-tumor effects support further evaluation in a combination setting with the goal of achieving meaningful patient benefit. That is why we are adding an EGFR mutant NSCLC cohort to our ongoing phase 1/2 study […]
Positive CHMP Opinion to Opdivo + Chemo as Neoadjuvant Treatment of Resectable NSCLC at High Risk of Recurrence in Patients with PD-L1 Expression
“The devastating reality is that despite progress in lung cancer treatment, many patients still ultimately end up relapsing and potentially dying of their disease,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Based on the results of the CheckMate -816 trial, Opdivo with chemotherapy is the first immunotherapy-based regimen to […]
FDA Removal of Partial Clinical Hold in the Ph 1 Clinical Trial for MT-0169
“We are pleased that the FDA has removed the partial clinical hold,” said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of MTEM. “MT-0169 represents a novel approach to myeloma that is demonstrating good safety with early signs of potential clinical benefit, particularly in the extramedullary setting, where we have seen a stringent Complete […]
Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated mCRPC
Andrew Armstrong, MD, ScM, of the Duke Cancer Institute, Durham, North Carolina, US, and an investigator in the trial, said: “Preventing or delaying radiographic progression or death is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers and their families. The PROpel results showed the Lynparza combination demonstrated […]
CONFERENCE COVERAGE: 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology Field
“Sony’s life science business has accumulated substantial knowledge in the field of cell analysis,” said Katsunori Ogawa, Head of Life Science & Technology Business Unit at Sony Corporation. “Through this collaboration, Sony is striving to contribute to the medical and drug discovery fields and provide further social value by leveraging Sony’s technological capabilities in the […]
IDEAYA Expands Clinical Trial Collaboration and Supply Agreements with Pfizer to Support Registrational Trial Evaluating Darovasertib and Crizotinib Combination in First-Line Metastatic Uveal Melanoma
“We are grateful to have Pfizer’s continued support – including their clinical expertise as a collaboration partner and with respect to drug supply, as we target initiation of our Phase 2/3 registrational trial in Q2 2023 for the darovasertib and crizotinib combination in first-line HLA-A2 negative MUM, with PFS as primary endpoint for potential accelerated […]
KSQ Therapeutics And Takeda Expand Strategic Immuno-Oncology Collaboration To Identify And Validate Novel Tumor Targets
“Expanding on our successful partnership with Takeda further validates the effectiveness of the CRISPRomics platform in discovering exciting, novel targets in various cell types across modalities,” said Qasim Rizvi, Chief Executive Officer of KSQ. “It also demonstrates KSQ’s ability to deliver results – our original collaboration, initiated in 2021 and focused on the discovery of […]
Ph 2 Clinical Trial initiated for CLDN18.2 CAR T-cell Product CT041 in the U.S.
Dr Raffaele Baffa, Chief Medical Officer of CARsgen, commented that, “Gastric cancer is a devastating disease that affects over a million people worldwide. Despite advances in treatment, the prognosis for patients with advanced gastric cancer remains poor, highlighting the urgent need for new and innovative therapies. CT041 has shown promising results in previous trials, demonstrating […]
Enrollment completed in Immune Checkpoint Inhibitor Naïve Arm of VERSATILE-002 Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer
“Completing enrollment in the ICI naïve arm is an important milestone in the VERSATILE-002 Phase 2 trial and the ongoing development of PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent and/or metastatic HPV16-positive head and neck cancer,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “HPV-driven HNSCC is a […]
First Patient dosed in AIPAC-003 Phase II/III Trial for Metastatic Breast Cancer
Immutep CSO, Prof Frédéric Triebel said: “Commencing patient dosing for our AIPAC-003 trial of efti is a significant milestone for Immutep. Our aim is to improve clinical outcomes, focusing on a robust primary endpoint later in the phase III, overall survival, for patients with standard-of-care chemotherapy. Our previous trial, AIPAC, showed encouraging efficacy and safety […]
Interim Data Demonstrates 12-Month Survival Rate of 87% with PDS0101 in Combination with KEYTRUDA® (pembrolizumab) for Head and Neck Cancer Patients
“We are pleased to present updated survival data from VERSATILE-002, which suggest the addition of PDS0101 to KEYTRUDA® may improve survival for the growing number of HPV16-positive head and neck cancer patients,” said Katharine A. Price, MD, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic and presenting author of the study.
Efti in Combination with Pembrolizumab Achieves Excellent Initial Overall Survival Benefit in 1L NSCLC
“Efti’s clinical results achieved to date in combination with pembrolizumab are increasingly robust and continue to justify the attention given to this novel IO-IO combination through invitations to make oral presentations at two prestigious conferences, ASCO and SITC, last year. We now are showing excellent initial overall survival, which is the gold standard benchmark within […]
Promising New Clinical Data Announced from Triple Combination Therapy in INSIGHT-003 Trial
Immutep CSO, Dr. Frédéric Triebel, said: “Immutep has made significant progress with our late-stage development planning to treat one of the largest cancer indications globally. We are uniquely positioned to address PD-L1 low (TPS 1-49%) and high (TPS >50%) expressing patients, representing roughly 65% of the non-small cell lung cancer patient population, with powerful chemo-free […]
Results for SC-DARIC33 in Pediatric and Young Adults with R/R AML announced
“The treatment of patients with relapsed and refractory AML represents a tremendous unmet medical need, particularly for pediatric and young adult patients. Progressing the promise of CAR T therapy, while mitigating potentially dose-limiting toxicity, has the potential to be a meaningful advance,” said Steven Bernstein, M.D., chief medical officer, 2seventy bio. “Together with Seattle Children’s […]
Update of Ongoing Ph 1 Study of Voruciclib +/- Venetoclax in Patients with AML or B-Cell Malignancies Announced
“These initial results provide encouraging support for the potential of voruciclib administered in combination with venetoclax to address a common resistance mechanism to venetoclax therapy and deliver improved clinical benefit to patients without significant myelosuppression,” said Dan Gold, Ph.D., president and chief executive officer of MEI Pharma. “We look forward to disclosing more data from […]
FAILED TRIAL: Ph 3 SAPPHIRE study of sitravatinib + (OPDIVO) vs docetaxel in patients with 2/3L advanced NSQ-NSCLC did not meet primary endpoint of OS
“Mirati extends gratitude to the patients who participated in this clinical trial, their loved ones, and the trial investigators, without whom important work like this would not have been possible,” said Alan Sandler, M.D., Chief Medical Officer. “As we move forward, we are optimistic about our ability to positively impact the lives of patients living with […]
KEYTRUDA + LENVIMA Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as 1L Treatment for Patients With Advanced RCC
“KEYTRUDA plus LENVIMA continues to demonstrate durable clinical benefit as a first-line treatment for patients with advanced renal cell carcinoma, as shown by the clinically meaningful improvement in overall survival sustained with four years of follow up,” said Dr. Thomas Hutson, DO, Pharm.D., FACP, Director of the Urologic Oncology Program and Co-chair of the Urologic […]
