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MedNess: bite-size biopharma and medtech news

22nd June, 2022
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Onco-This-Week
HIGHLIGHTS
 
Regulatory News
sBLA accepted for KEYTRUDA® as Adjuvant Therapy for Stage IB (≥4 centimeters)-IIIA Non-Small Cell Lung Cancer Following Complete Surgical Resection
“KEYTRUDA is foundational in the treatment of metastatic non-small cell lung cancer. The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “If approved, KEYTRUDA would be the first adjuvant immunotherapy-based option in the U.S. for patients with stage IB (≥4 centimeters) to IIIA non-small cell lung cancer following surgical resection regardless of PD-L1 expression.”
Trial Results
EHA 2022: Results from Ph 2 Trial of Epcoritamab (DuoBody®-CD3xCD20) in Patients with R/R Large B-cell Lymphoma (LBCL) announced
"Large B-cell lymphoma is a fast-growing, difficult to treat type of aggressive non-Hodgkin's lymphoma. Some treatment approaches like chemotherapy and immunotherapy have been in place for decades and newer treatments like CAR T-cell therapies involve multiple steps before a patient can begin treatment so there is still a need for additional treatment options," said Professor Catherine Thieblemont, head of the Hemato-Oncology Department at Hôpital Saint-Louis, Paris, France. "The data presented today suggest that epcoritamab has the potential to provide patients living with LBCL an accessible, effective treatment with a safety profile that may fulfill an unmet need."
Positive Initial Data from Pivotal FIREFLY-1 Trial of Tovorafenib (DAY101) in Relapsed Pediatric Low-Grade Glioma Announced
“These initial findings underscore the potential of tovorafenib monotherapy to become a significant and transformative new option for relapsed/progressive pLGG, a pediatric brain tumor with no approved treatments today,” said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. “With the registrational cohort fully enrolled, patient follow-up is ongoing, and we look forward to the topline data from the complete study population in the first quarter of 2023. Based on these positive initial data, we plan to begin the pivotal Phase 3 FIREFLY-2 clinical trial evaluating tovorafenib as a front-line therapy in pLGG to evaluate whether tovorafenib can provide benefit early in the disease development.”
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Trial/Program Status
TROPION-Breast02 Ph 3 Trial of Datopotamab Deruxtecan Initiated in Patients with 1L mTNBC
“Patients with metastatic triple negative breast cancer who are not able to receive PD-1/PD-L1 inhibitor treatment often experience recurrence following chemotherapy, so additional options in the first-line treatment setting are needed,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “The TROPION-Breast02 trial will build on the preliminary efficacy and safety profile seen in the relapsed or refractory triple negative breast cancer arm of the TROPION-PanTumor01 trial to evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients in the first line setting.”
Enrollment completed in PRESERVE 1 Ph 3 clinical trial of trilaciclib for patients with metastatic colorectal cancer (mCRC) receiving chemotherapy
“FOLFOXIRI is an important chemotherapeutic backbone for people diagnosed with CRC because it is highly efficacious and has shown a survival advantage compared to other chemotherapeutic options; however, it is also the most myelotoxic regimen, so patients may have dose delays and reductions or receive less effective chemotherapeutic regimens - both of which could impact patient outcome and survival,” said Raj Malik, M.D., G1’s Chief Medical Officer. “Trilaciclib may be an important addition to this regimen due to its unique ability to preferentially protect the bone marrow from chemotherapy-induced toxicities, and its potential to preserve immune system function and improve survival. Both endpoints are being assessed in PRESERVE 1. We are happy to have completed enrollment, and look forward to presenting initial data, including the primary endpoint of the trial, in the first quarter of 2023. This is a registrational trial; if the data from the primary endpoint are positive, we would work closely with the FDA to expedite our filing for regulatory approval in this indication.” 
MedNess Business
Onco-News
ImmunoGen Announces Research Collaboration with Oxford BioTherapeutics to Develop Novel Antibody-Drug Conjugates
"OBT has demonstrated expertise in identifying novel targets for the development of specific antibodies - two key components to generating successful ADCs," said Stacy Coen, ImmunoGen's Senior Vice President and Chief Business Officer. "This expertise, combined with ImmunoGen's portfolio of cancer-killing payloads and linkers, will be instrumental as both companies work to develop novel ADCs designed to address cancers with high unmet need. We look forward to working with OBT as we expand and diversify our investment in ADC research capabilities, deepen our pipeline, and transition to a fully-integrated oncology company'.
Pfizer, MorphoSys and Incyte Enter into Clinical Trial Collaboration for Monjuvi® (tafasitamab-cxix) + TTI-622
‟Monjuvi in combination with lenalidomide is an important treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma, and its mechanism of action, efficacy and safety profile make it an attractive combination partner,” said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. “We believe that the addition of novel immunotherapies, such as the investigational anti-CD47 blocking agent TTI-622, to the backbone of Monjuvi plus lenalidomide have the potential to provide new meaningful combination treatment options for patients with relapsed or refractory diffuse large B-cell lymphoma.”  
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Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Consulting 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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