Dor

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

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화요일, 4월 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

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목요일, 3월 28, 2024
OS, Savolitinib, Conference, NMPA, AstraZeneca, NSCLC, Grade 3, DCR, New Drug Application, WCLC, Patient, Neoplasm, Cerebral edema, Gamma-glutamyltransferase, MET, Lung cancer, HKEX, Dor, Safety, PFS, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points: 
  • Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
  • Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
  • More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
  • The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status

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화요일, 4월 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, Neoplasm, NDA, Cancer, Breakthrough therapy, Senior, HCM, HKEX, Dor, IRC, Prognosis, PFS, Ophthalmology, Pharmaceutical industry

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.
  • We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China."
  • We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
  • The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023.

RemeGen Presents Oral Presentation on Evaluation of Its Proprietary Disitamab Vedotin (RC48) for Cervical Cancer at ESGO 2024

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월요일, 3월 11, 2024
HER2, Cervical cancer, Congress, ECOG, Immunotherapy, Progression-free survival, DCR, Patient, Research, IIB, Șaeș, Safety, Dor, Carcinoma, ESGO, Adenocarcinoma, PFS, FIGO, ADC, Independent Review Committee, Pharmaceutical industry

The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+.

Key Points: 
  • The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+.
  • As of October 31, 2023, 25 patients with cervical cancer were enrolled with a median age of 56 years (range: 35-66).
  • In conclusion, RC48 demonstrates a manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it to be a promising new treatment for HER2-expressed cervical cancer.
  • I am delighted to share an oral presentation on the evaluation of our proprietary ADC Disitamab Vedotin at ESGO 2024.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023

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월요일, 2월 26, 2024
Borderline personality disorder, HOPE, HDAC6, National Cancer Institute, EVOLUTION, CMT, Agitation, Data analysis, Convertible bond, ICIS, ALS, SCLC, Azacitidine, Duration, ICI, IIS, Sciatic nerve, Deficit spending, Paclitaxel, DSM-IV codes, Development, Genomics, ALS Association, FMS, LSD1, AML, Clinical Global Impression, MSKCC, Conference, Aggression, Safety, Biomarker, CNS, Venetoclax, CRADA, OHSU, MRD, Clinical trial, BPD, Measure (mathematics), IND, FCCC, Dor, Human, Innovation, EMA, Kabuki syndrome, NET, NCI, Aes, Glomus tumor, FDA, GST, Food, Platinum, Schizophrenia, Phase II, Charcot–Marie–Tooth disease, Medicine, Patient, BEST, Disease, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.
  • Research and development (R&D) expenses were $3.9 and $16.6 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $5.0 and $18.1 million for the quarter and twelve months ended December 31, 2022.
  • General and administrative expenses were $1.2 and $4.2 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.2 and $4.8 million for the quarter and twelve months ended December 31, 2022.
  • Net losses were $1.4 and $5.0 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.6 and $5.9 million for the quarter and twelve months ended December 31, 2022.

Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority

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금요일, 2월 2, 2024
Orbis, HC, JAMA, TGA, HSA, European, Shirin David, Immunotherapy, Trial of the century, Nasopharyngeal carcinoma, NPC, PFS, Clutch (eggs), Cisplatin, Patient, Safety, ASCO, New Drug Application, American Medical Association, Shanda, Progression-free survival, FDA, Marketing, OCE, Dor, Food, Society, Health Canada, Risk, Journal, Death, Health care, NDA, HKEX, Pharmaceutical industry

This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).

Key Points: 
  • This NDA was submitted through Project Orbis, an initiative of the US Food and Drug Administration (FDA)’s Oncology Center of Excellence (OCE).
  • At present, eight regulatory agencies have joined Project Orbis, including the FDA, the Australia Therapeutic Goods Administration (“TGA”), HSA, Health Canada (HC), the U.K.
  • Previously, two NDAs for toripalimab for the treatment of NPC had been submitted to the TGA through Project Orbis and were successfully accepted.
  • Junshi Biosciences will explore accelerated marketing opportunities in countries and regions where it is applicable.

Junshi Biosciences Announces Publication of Results from TORCHLIGHT, a Randomized Phase 3 Trial of Toripalimab for the Treatment of Metastatic or Recurrent Triple-negative Breast Cancer in Nature Medicine

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수요일, 1월 10, 2024
Development, Oncology, Patient, Progression-free survival, OS, DCR, Survival, Dor, PD, Immunotherapy, RECIST, Aes, CSCO, Triple-negative breast cancer, PFS, Safety, HR, TNBC, ITT, Pharmaceutical industry

TORCHLIGHT is the first registered Phase 3 study to achieve positive results in advanced TNBC immunotherapy in China.

Key Points: 
  • TORCHLIGHT is the first registered Phase 3 study to achieve positive results in advanced TNBC immunotherapy in China.
  • A total of 300 patients had PD-L1-positive TNBC: 200 in the toripalimab arm and 100 in the control arm.
  • TORCHLIGHT’s results show that the addition of toripalimab to nab-paclitaxel significantly improved PFS for PD-L1-positive patients with metastatic or recurrent TNBC, while maintaining an acceptable safety profile.
  • The groundbreaking outcomes of this study has the potential to address unmet clinical needs and offer Chinese TNBC patients better treatment options.”

Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs)

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월요일, 12월 11, 2023
Patient, EST, Haematopoietic system, Dor, EFS, MD Anderson Cancer Center, Graft-versus-host disease, Society, Cancer, ASH, HL, CRS, PST, Webcast, Safety, University, BV, Pharmaceutical industry

Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig’s future development.

Key Points: 
  • Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig’s future development.
  • A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D.
  • 32 of the 36 patients treated at the RP2D were HL patients.
  • For the HL patients treated at the RP2D, median EFS was 9.8 months - with 84% patients alive at 12 months.

Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes

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월요일, 12월 11, 2023
Telephone, Regeneron Pharmaceuticals, Quality of life, Food, Quality of life (healthcare), Treatment, Fever, DLBCL, EMA, FDA, CD20, Cytokine release syndrome, Dor, Anemia, Neutropenia, Pros, Orphan, Society, Research, B-cell lymphoma, ASH, Neuropsychological test, ICR, COVID-19, European Medicines Agency, ID, Fast track (FDA), University of Nantes, CRS, Webcast, Patient, Safety, Medicine, PFS, Pharmaceutical industry

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data for odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) from a pivotal Phase 2 trial (ELM-2). These data – which include updated efficacy, safety and patient-reported outcomes (PROs) – were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
  • “As clinicians, our focus must remain patients’ wellbeing, along with favorable outcomes.
  • For odronextamab, it is particularly encouraging to see the unprecedented clinical results complemented by patient-reported outcomes that show quality of life and functional measures are maintained overall.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes

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일요일, 12월 10, 2023
DLBCL, IPI, Cytokine release syndrome, CD20, Anemia, International, Dor, Neutropenia, City, Society, B-cell lymphoma, ASH, ICR, CRS, Patient, Phase II, Regeneron Pharmaceuticals

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The data from the pivotal Phase 2 trial (ELM-2) and Phase 1 trial (ELM-1) were shared in several presentations – including two orals – at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
  • “Diffuse large B-cell lymphoma has a high risk of relapse, which is why it is so critical to demonstrate continued disease control over the long term.
  • “The primary analysis from the pivotal trial of odronextamab demonstrated impressive response rates, including in certain high-risk subgroups.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.