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MedNess: bite-size biopharma and medtech news

15th December, 2021
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MedNess This Week
HIGHLIGHTS
 
Regulatory News

NDA Submitted for Poziotinib for use in patients with previously treated locally advanced or mNSCLC with HER2 exon 20 insertion mutations
“The NDA submission for poziotinib marks an important step in achieving a first treatment for patients with HER2 exon 20 insertion mutations in lung cancer,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “I want to thank the patients, investigators and our internal staff who have passionately worked to achieve this important milestone in an area of high unmet medical need.”
Anticipated Regulatory Path Forward for Vicineum™Announced
“We are pleased to have greater clarity on the regulatory path forward to resubmit the BLA and ultimately bring Vicineum to market if approved,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “Our team looks forward to working productively with regulators as we continue to focus on our mission of saving and improving the lives of patients.”
Trial Results
New data from the Ph 2 CITYSCAPE trial show encouraging results with anti-TIGIT tiragolumab plus Tecentriq
“These encouraging results suggest that combining anti-TIGIT and anti-PD-L1 cancer immunotherapies such as tiragolumab and Tecentriq could potentially represent a novel approach to address unmet needs in cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With tiragolumab, we have the largest and most advanced anti-TIGIT clinical programme, and we look forward to the results of our phase III trials in lung cancer and other challenging tumour types.”
Trial/Program Status
First Patient Dosed in AGILITY Ph 3 Clinical Trial of Entospletinib in Patients With Newly Diagnosed NPM1-mutated AML
“With the initiation of this trial, we are taking an important step forward for patients with AML, a form of blood cancer that has been difficult to treat historically,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “Even with current therapies, about half of people newly diagnosed with NPM1-mutated AML will die from the disease within five years. The use of the novel endpoint of MRD provides a pathway to potentially bring entospletinib to patients more quickly.”
Click here for more Trial Statuses
Collated by: Richa Tewari, PhD 
CONFERENCE COVERAGE: 63rd ASH Annual Meeting
  1. Axi-cel CAR T cell therapy shows enhanced responses and continued benefit for high-risk lymphoma patients
  2. BeiGene Presents Results from SEQUOIA Trial of BRUKINSA (zanubrutinib) in 1L CLL
  3. BLINCYTO® (blinatumomab) Data Demonstrate Superior OS in Pediatric Patients With Relapsed ALL in Longer Follow-up of Phase 3 Trial
  4. BMS’ Breyanzi (lisocabtagene maraleucel) Significantly Improves Outcomes, Showing Superiority Over 20-Year SoC in 2L R/R Large B-cell Lymphoma Based on TRANSFORM Study Results
  5. Calquence reduced the risk of disease progression or death by 71% vs. standard of care combinations at three years in the ASCEND Ph 3 trial
  6. Epizyme Presents Preclinical Data and Ph 1/1b Trial Design on SETD2 Inhibitor, EZM0414
  7. Epizyme Presents Updates from SYMPHONY-1 Tazemetostat + R² Combination Study in R/R Follicular Lymphoma
  8. First Presentation of Efficacy and Safety Data With Subcutaneous BLINCYTO Administration in Patients With R/R ALL
  9. ImmunoGen Presents Initial Findings From the Ph 1b/2 Study of IMGN632 in Combination With Vidaza® and Venclexta® in R/R AML
  10. Incyte Announces Updated Data Demonstrating Rapid and Durable Responses of Parsaclisib in Patients with R/R B-Cell NHL
  11. Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma
  12. Jazz Pharmaceuticals Presents Positive Interim Ph 2/3 Results of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) in ALL or LPL
  13. Loxo Oncology at Lilly Announces Updated Data from the Ph 1/2 BRUIN Clinical Trial for Pirtobrutinib
  14. MorphoSys and Incyte Announce Additional RWE Results from RE-MIND2 Study of Tafasitamab (Monjuvi®) + Lenalidomide for the Treatment of R/R DLBCL
  15. New Clinical and Real-World Data Support Use of DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma
  16. New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
  17. New Data from Ph 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) + Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in 1L CLL
  18. New data from the Ph 2 CITYSCAPE trial show encouraging results with Roche’s novel anti-TIGIT tiragolumab plus Tecentriq
  19. New REGN5458 (BCMAXCD3) Ph 1 data show 75% response rate at highest dose levels studied in patients with heavily pretreated multiple myeloma
  20. Novartis Kymriah® demonstrates strong responses in high-risk patients with R/R FL in extended study follow-up
  21. Novartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with CML
  22. Ph 3 Data Demonstrate TIBSOVO® (ivosidenib tablets) + Azacitidine Significantly Improves EFS and OS in Patients with 1L IDH1-mutated AML
  23. Roche presents pivotal data for novel cancer immunotherapy mosunetuzumab
  24. Roswell Park Hematologists Present New Research on FLT3 Inhibitors, CART-19
  25. Sarclisa® (Isatuximab) Trial Is First Ph 3 Study To Meet Primary Endpoint Of MRD Negativity In Transplant-Eligible Patients With 1L Multiple Myeloma
  26. Valemetostat Pivotal Data Shows Promising Response Rates in Patients with Adult T-Cell Leukemia/Lymphoma
  27. Yescarta® CAR T-Cell Therapy Quadruples Median EFS Duration Over Standard of Care in 2L R/R Large B-Cell Lymphoma
  28. Yescarta® Demonstrates Durable Two-Year Clinical Benefit in Adults With R/R iNHL Including Follicular Lymphoma
  29. Yescarta® Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study Showing Durable Long-Term Survival in Patients With Refractory LBCL
  30. Roche’s Polivy Combination Reduced The Risk Of Disease Worsening Or Death By 27% In People With 1L DLBCL
  31. Seagen Announces Preliminary Results from Ph 2 Clinical Trial of ADCETRIS® (brentuximab vedotin) in Novel Combination of Agents for Patients with Advanced Stage cHL
  32. Novartis announces T-Charge™, next-generation CAR-T platform with first-in-human data
  33. Two-Year Analysis of CARTITUDE-1 Shows Early, Durable and Deepening Responses of Ciltacabtagene Autoleucel (cilta-cel) in Heavily Pretreated Patients with Multiple Myeloma
  34. Yescarta® ZUMA-12 Study Demonstrates 78% Complete Response Rate as Part of First-Line Treatment in Newly Diagnosed High-Risk Large B-Cell Lymphoma
  35. New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
  36. New data highlight potential of Blenrep (belantamab mafodotin-blmf) in combination with standard of care therapies in earlier lines of multiple myeloma treatment
  37. Mustang Bio Announces Updated Interim Ph 1/2 Data for MB-106 in Patients with R/R B-cell NHL and CLL
  38. Allogene Therapeutics Reports Positive Results from Ph 1 UNIVERSAL Study of Single Dose ALLO-715 AlloCAR T™ Cell Therapy in R/R Multiple Myeloma
  39. Cellectar Presented Data from its Ongoing Phase 2 CLOVER-1 Study of Iopofosine I-131
  40. Actinium Pharmaceuticals Reports 2 Remissions and 67% ORR in Patients with a TP53 Mutation in the Ph 1 portion of the Actimab-A Venetoclax Combination Trial in Patients with Relapsed or Refractory AML
  41. Actinium Pharmaceuticals Announces Greater Difference of Approximately 5x for Iomab-B vs Control Arm in the Number of Patients Potentially Evaluable for the Primary Endpoint of the Pivotal Ph 3 SIERRA Trial
  42. Actinium Pharmaceuticals Announces 72% MRD Negativity Rate in the Recently Completed Ph 1 Study of Actimab-A + CLAG-M for Patients with R/R AML
  43. Aprea Therapeutics Presents Primary Analysis from Ph 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML
  44. TG Therapeutics Announces Data from the UNITY-CLL Ph 3 Trial
CONFERENCE COVERAGE: 2021 San Antonio Breast Cancer Symposium (SABCS)
  1. Ambrx Biopharma Inc. Presents Positive Data from Ongoing ACE-Breast-01 Ph 1 Clinical Study of ARX788
  2. Arvinas and Pfizer Announce PROTAC® Protein Degrader ARV-471 Continues to Demonstrate Encouraging Clinical Benefit Rate in Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer
  3. Carrick Therapeutics Presents Encouraging Clinical Data for Samuraciclib (CT7001)
  4. Datopotamab Deruxtecan Continues to Show Promising Durable Response and Disease Control in Patients with mTNBC
  5. Encouraging Updated Data from Ph 2 MARIO-3 TNBC Trial presented
  6. Enhertu additional analyses further reinforce efficacy in patients with HER2-positive metastatic breast cancer
  7. New Kisqali® data shows consistent OS benefit across genomic and clinical subtypes of interest in HR+/HER2- metastatic breast cancer
  8. Novartis data highlight efficacy of Piqray® in HR+/HER2- metastatic breast cancer with a PIK3CA driver mutation immediately post-CDK4/6i
  9. Positive EMERALD Trial Results for Elacestrant Presented
  10. Trodelvy® Demonstrates Clinical Benefit for Black Patients Consistent with Full mTNBC Population in ASCENT Study
  11. Seagen Announces Updated Results from Pivotal HER2CLIMB Trial Evaluating TUKYSA® (tucatinib) in Patients with HER2-Positive Breast Cancer with Brain Mets
MedNess Business
  Onco-News
SpringWorks Therapeutics Announces Clinical Collaboration with AbbVie to Evaluate Nirogacestat in Combination with ABBV-383 in Patients with R/R Multiple Myeloma
“We continue to progress our strategy to evaluate nirogacestat in combination with BCMA therapies for patients with multiple myeloma and are delighted to enter into our seventh BCMA clinical collaboration. We look forward to working with AbbVie to study nirogacestat in combination with ABBV-383,” said Saqib Islam, Chief Executive Officer of SpringWorks. “Together with our industry-leading collaborators, our goal remains to meaningfully improve clinical outcomes for patients with multiple myeloma.”
Collated by: Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Shilpa Rawal, PhD
Onco I-Analyse
Arundithi Ananthanarayanan
MedNess Reviews
Debarati Banik
HealthIT
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Rinki Saha
BioPharma News
Managing Editor
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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