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MedNess: bite-size biopharma and medtech news

19th May, 2021
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MedNess This Week
HIGHLIGHTS
Onco-I-Analyse
Keytruda met the dual primary endpoint in Phase 3 study in high-risk TNBC
On 13th May, Merck announced that Keytruda (pembrolizumab) in combination with chemotherapy as neoadjuvant therapy and as adjuvant monotherapy met the dual primary endpoint of event free survival (EFS) in the registrational Phase 3 neoadjuvant/adjuvant KEYNOTE-522 in high-risk triple-negative breast cancer (TNBC) patients. 
Background: Early stage TNBC is an area of high unmet need with poorer outcomes and survival. Chemotherapy is the only standard of care for high-risk early stage TNBC patients.
Details: Keytruda was being evaluated as a neoadjuvant therapy in combination with chemotherapy and as monotherapy adjuvant treatment in a placebo controlled Phase 3 KEYNOTE-522 study which enrolled 1,174 patients.
During an interim analysis by Independent Data Monitoring Committee (IDMC), neoadjuvant Keytruda + chemo followed by adjuvant Keytruda demonstrated statistically significant benefit in the EFS over chemo/placebo.
In 2019, Keytruda was shown to demonstrate the other primary endpoint of pathological complete response (pCR), regardless of the PD-L1 status.
Implications: Earlier in March, the FDA had issued a complete response letter (CRL) to Merck denying Keytruda’s sBLA application in high-risk, early stage TNBC based on pCR and early EFS data. The regulatory decision was deferred until mature EFS data was available as per ODAC’s unanimous vote. The recent data might support Keytruda’s sBLA, with some analysts believing that an approval can be expected as early as next year.
 
Collated by : Shilpa Rawal, PhD
Trial Results
Positive results announced from Ph 3 trial of Libtayo® (cemiplimab) in patients with recurrent or metastatic cervical cancer
"In this Phase 3 trial, Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population," said Krishnansu S. Tewari, M.D., Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator. "Improvements in progression-free survival and objective response rate were also demonstrated in the overall population compared to chemotherapy. Taken together, this landmark trial – which enrolled patients regardless of PD-L1 expression status – helps support the use of Libtayo as a potential new second-line treatment for women with advanced cervical cancer who face a poor prognosis and limited treatment options."
Ph 1/2 GBM Data Shows Temferon™ Delivered Tumor-Focused Interferon Expression
Carlo Russo, Chief Medical Officer at Genenta Science, said: “These preliminary results provide exciting indications that Temferon acts in the way we anticipated even in the relatively inaccessible setting of glioblastoma multiforme. The data are encouraging and in line with our pre-clinical results, with early evidence that Temferon delivers biological effects that may impact the progression of individual lesions.”
Click here for more Trial Result
Trial/Program Status
Randomized double-blind placebo-controlled Ph 2 study of cosela™ (trilaciclib) in NSCLC (PRESERVE 4) Initiated
“Non-small cell lung cancer is the most common type of lung cancer, accounting for nearly 85% of all diagnoses, and remains a great unmet medical need,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “Despite improvements in therapy for metastatic NSCLC, including the use of PD-1 or PD-L1 inhibitors, the majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy. In addition to the need for therapies that more effectively extend overall survival, patients treated in the metastatic setting are particularly vulnerable to chemotherapy-induced myelosuppression and health-related quality of life impacts associated with systemic chemotherapy. We are exploring both potential benefits of COSELA in PRESERVE 4.”
Enrollment in the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma completed
James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, “We are pleased to report the completion of enrollment for our metastatic cSCC cohort, with over 75 patients enrolled, which we expect will enable a readout of top-line results in the fourth quarter of this year.” Mr. Oliviero continued, “Based on the interim data presented last year at the European Society for Medical Oncology (“ESMO”) Virtual Congress 2020 and the Society for Immunotherapy of Cancer (“SITC”) 35th Anniversary Annual Meeting, we believe cosibelimab has the potential to be a best-in-class anti-PD-L1 antibody, which we intend to commercialize at a substantially lower price in comparison to currently marketed anti-PD-(L)1 therapies. With a compelling safety and efficacy profile, as well as our market disruptive pricing strategy, we believe cosibelimab can achieve meaningful and rapid market share in the $25 billion and growing PD-(L)1 class.”
Click here for more Trial Statuses
CONFERENCE COVERAGE: European Hematology Association (EHA) 2021
  1. Beigene to present BRUKINSA data from ASPEN and ALPINE trials and Long-Term Follow-up Data of Tislelizumab in Classical Hodgkin’s Lymphoma (cHL)
  2. BMS to present First Ph 3 data from the RELATIVITY-047 of relatlimab, First results from CheckMate-648 of Opdivo + Yervoy and Opdivo in advanced ESCC, long-term Opdivo plus Yervoy data in NSCLC and metastatic melanoma, new long-term results from KarMMa study of Abecma and combination data from iberdomide in patients with multiple myeloma
  3. bluebird bio to present updated results from the Ph 3 Northstar-2 (HGB-207) & Northstar-3 (HGB-212) studies, as well as long-term efficacy and safety results from the LTF-303 follow-up study
  4. Immunicum AB to present two posters on off-the-shelf relapse vaccine DCP-001
  5. Incyte to present real-world data for ruxolitinib, and Ph 2 combination study of ruxolitinib and parsaclisib in patients with myelofibrosis
  6. Legend Biotech Reports New and Updated Data from BCMA CAR-T Program
  7. MEI Pharma and Kyowa Kirin to Present Clinical Data from Ph 1b Study of Zandelisib in Combination with Zanubrutinib
  8. Mustang Bio to present MB-106 CD20-Targeted CAR T Data
  9. Sierra Oncology to present new analyses from the previously completed SIMPLIFY-1 and SIMPLIFY-2 studies
  10. X4 Pharmaceuticals Announces Positive Preliminary Data from Ongoing Phase 1b Clinical Trial of Mavorixafor in Waldenström’s Macroglobulinemia
MedNess Business
Onco-News
Checkmate Pharmaceuticals Announces Clinical Supply Agreement with Regeneron to Evaluate Vidutolimod (CMP-001) in Combination with Libtayo® (cemiplimab)
“We’re pleased to collaborate with Regeneron as we expand evaluation of vidutolimod as a potent stimulator of innate immune activity to patients with life-threatening non-melanoma skin cancers such as CSCC and MCC,” said Barry Labinger, President and Chief Executive Officer of Checkmate. “We look forward to advancing vidutolimod in combination with Libtayo to further unlock the capabilities and impact of immuno-oncology therapeutics.”
Ipsen opts-in to join Exelixis with ongoing development of Cabometyx® for people living with a form of thyroid cancer, based on promising interim results
Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen, commented:
“A planned interim analysis of the COSMIC-311 Phase III trial has shown promising and clinically meaningful results in the use of Cabometyx in people living with radioiodine-refractory differentiated thyroid cancer who have progressed after prior therapy. We are delighted to build on our strong foundation and join Exelixis to further evaluate, and to work with regulatory authorities on, the potential of Cabometyx in a patient population who currently have limited treatment options.”
Click here for more on mergers, acquisition and business news
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Shilpa Rawal, PhD
Onco I-Analyse
Debarati Banik
HealthIT
Rinki Saha
BioPharma News
Managing Editor
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Managing Editor
Abhi Dey
Consulting Editor
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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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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