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MedNess: bite-size biopharma and medtech news

20th October, 2021
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MedNess This Week
HIGHLIGHTS
Onco-I-Analyse
Merck’s Keytruda gets nod for first line treatment of Cervical Cancer
On 13th October, the US FDA approved Keytruda in combination with chemotherapy, with or without bevacizumab for the treatment of patients with persistent, recurrent or metastatic, PD-L1+ cervical cancer. The approval was based on data from the Phase 3  KEYNOTE-826 clinical trial.
Background: Cervical cancer is one of the leading causes of death in women globally. Persistent, recurrent or metastatic cervical cancer is associated with poor prognosis, with a 5-year survival rate of approximately 17%. Limited treatment options exist in advanced stages of cervical cancer.
Details: The KEYNOTE-826 trial evaluated Keytruda + Investigator choice chemotherapy (paclitaxel + cisplatin/ carboplatin) ± bevacizumab versus chemotherapy ± bevacizumab in 617 patients with persistent, recurrent, or metastatic cervical carcinoma, not treated with systemic chemotherapy.
In patients with PD-L1+ tumors (CPS ≥1), there was a statistically significant difference in key primary endpoints with 36% risk reduction in death and mOS (Not reached vs. 16.3 months; HR: 0.64, P1-sided: 0.0001)), mPFS (10.4 vs. 8.2 months; HR: 0.62, P1-sided: <0.0001). The Keytruda arm also had improved ORR (68% vs. 50%) and mDOR (18.0 vs. 10.4 months).
 The review was conducted under the Project Orbis initiative used Assessment Aid. The application was also granted priority review by the FDA with approval coming 4 months ahead of the designated PDUFA date.
The FDA also converted Keytruda’s accelerated approval to regular approval as a single agent for the treatment of PD-L1+ (CPS≥1), recurrent or metastatic cervical cancer following disease progression on or after chemotherapy.
Implications: This is the first approval for a checkpoint inhibitor combination therapy in frontline Cervical cancer. However, the label is restricted to PD-L1+ patient population, despite an improvement in the broader patient pool as Keytruda could not show a benefit in 69 patients with PD-L1 CPS<1.
As per SVB Leerink analyst Keytruda sales in metastatic cervical cancer are projected at $114 million in 2025 of a $174 million total for all PD-1/L1s.
Collated by: Shilpa Rawal, PhD
Drug Approvals
FDA approves Tecentriq as adjuvant treatment for PD-L1-positive Stage II-IIIA lung cancer patients based on Ph 3 IMpower010 study results
“Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.”
FDA Approves Verzenio® (abemaciclib) for patients with HR+ HER2-, node-positive, high risk early breast cancer and a Ki-67 score of ≥20%
"Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, senior vice president, CEO of Loxo Oncology at Lilly and president, Lilly Oncology. "We are pleased with this initial approval in the adjuvant setting and as these data continue to mature, we look forward to further opportunities to work with health authorities to expand the use of Verzenio in this setting."
Click here for more Drug Approvals
Regulatory News

Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced NSCLC with EGFR Ex 20 Insertion Mutations, After Failure of Platinum-based Therapy
“Following the U.S. FDA approval of RYBREVANT® earlier this year, we are extremely pleased that the CHMP has granted Janssen a positive opinion for amivantamab, the first such opinion for a product created using Genmab’s DuoBody technology platform. We are hopeful that this opinion will lead to an approval and to the first treatment option for European patients with advanced NSCLC with activating EGFR exon 20 insertion mutations,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Anti-TROP-2 ADC with a drug payload SN38 (ESG-401) received FDA authorization to begin clinical trials in the US
  • Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approved the Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate.
  • US FDA also gave clearance to proceed with clinical trials in cancer patients with relapsed or refractory solid tumors.
Click here for more Regulatory News
Trial Results
Imfinzi + tremelimumab significantly improved OS in HIMALAYA Ph 3 trial in 1L unresectable liver cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Inhibition of CTLA-4 has shown the ability to drive benefit particularly in the tail of the survival curve in several settings. This is the first time a dual immunotherapy regimen has improved overall survival as a 1st-line treatment for patients with unresectable liver cancer for whom treatment options are limited and long-term outcomes are poor.”
Positive Results Reported from Ph 1 CARBON Trial of CTX110™ in Relapsed or Refractory CD19+ B-cell malignancies
“We are excited to share positive data from our CARBON trial, which show that CTX110 could offer patients with large B-cell lymphomas an immediately available ‘off-the-shelf’ therapy with efficacy similar to autologous CAR-T and a differentiated safety profile,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “Furthermore, we have the potential to improve upon already observed efficacy with a consolidation dosing strategy. Based on these encouraging results, we are planning to expand CARBON into a potentially registrational trial in the first quarter of 2022.”
Click here for more Trial Results
Trial/Program Status
First Patient Dosed With PVSRIPO in Ph 1/2 LUMINOS-103 Bladder Cancer Sub-Study
“PVSRIPO has shown impressive responses with monotherapy in patients participating in two phase 1 clinical trials focused on glioblastoma and melanoma,” said Matt Stober, president and CEO at Istari Oncology. “We look forward to further evaluating its therapeutic value as we aim to expand the potential treatment options for patients living with bladder cancer.”
First Patient Enrolled in International Ph 3 ARTEST Clinical Trial of Enobosarm in Metastatic Breast Cancer
“While endocrine therapies have been the mainstay of breast cancer treatment for decades, these therapies have all focused on the estrogen receptor. Targeting the AR, a demonstrated tumor suppressor, provides us with an opportunity to bring a truly novel hormone treatment approach to patients who have AR+ER+HER2- metastatic breast cancer,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. “We already have substantial safety information about enobosarm therapy as it has been evaluated in 25 clinical trials comprising over 2,000 patients with approximately 350 patients dosed at 9mg or higher doses. Enobosarm is well tolerated and has also resulted in improvements in quality of life including reported better physical function, mobility, and pain in metastatic breast cancer patients. Furthermore, a recent Phase 2 study in heavily pretreated patients with metastatic breast cancer confirmed that enobosarm’s efficacy was best in women that had 40% or greater expression of the androgen receptor in their breast cancer.”
Click here for more Trial Statuses
Collated by: Richa Tewari, PhD 
   MedNess Plus
Apnimed Shows Positive Phase 2 Data with an Oral Pharmacologic Treatment for Obstructive Sleep Apnea
 Larry Miller, M.D., Chief Executive Officer of Apnimed said in a statement, “We are extremely encouraged by these results which continue to reinforce the potential of AD109 to have a clinically meaningful benefit for patients with mild to moderate OSA”. “Both doses studied in this clinical trial led to statistically significant improvements across multiple measures of disease severity and demonstrated clear evidence of a dose-response.” AD109 is an investigative, oral pharmacological combination drug which includes a selective norepinephrine reuptake inhibitor and a selective muscuranic to maintain an open airway during sleep. This drug has been designed to treat OSA patients with a broad range of severity and patients with both the high and low dosage treatment shows significant difference from placebo treated individuals in their Hypoxic Burden (HB), a measure of the total amount of respiratory event-related hypoxemia, or low blood oxygen during sleep after a single dose. 
FDA Grants Breakthrough Therapy Designation to Roche’s Anti-amyloid Beta Antibody, Gantenerumab in Alzheimer’s Disease Treatment 
“This Breakthrough Therapy Designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimer’s disease with the potential for at-home administration,” says Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. Breakthrough Therapy Designation aims to accelerate the development of medicines, to treat life-threatening conditions, which show evidence of significant improvement over available FDA-approved treatments. Alzheimer’s disease (AD) is characterized by the buildup of amyloid plaques, large accumulations of the protein, beta-amyloid. Gantenerumab is an investigational IgG1 antibody that has been shown to reduce amyloid plaques in patients with AD in two different studies and is now being tested in two different Phase III trials of optimized design which are expected to be completed in 2022.
Collated by: Sohini Dutta, PhD 
MedNess Business
 Onco-News
Turning Point Therapeutics and EQRx to Evaluate Elzovantinib + Aumolertinib in Patients with EGFR Mutant Met-Amplified Advanced NSCLC
“We believe the combination of elzovantinib with aumolertinib could provide an important potential treatment option for patients who develop MET amplification as acquired resistance to an EGFR inhibitor, where no approved therapies are available today,” said Athena Countouriotis, M.D., president and chief executive officer of Turning Point. “We are pleased to have EQRx as our collaboration partner and look forward to initiating our Phase 1b/2 SHIELD-2 study of the combination.”
BioPharma News
MindMaze secures $125 million for neuro-rehabilitation video game platform acceleration and commercialization 
Tej Tadi, PhD, MindMaze founder and CEO stated, “This investment by AlbaCore will allow us to accelerate our proven neuro-rehab platform and advance commercialization of our evidence-based neuro-restorative solutions in stroke, traumatic brain, aging and Parkinson disease. One avenue to pursue will be to partner with pharmaceutical companies to promote brain repair by combining our digital therapeutic neurorestorative approach with emerging drug discovery.” MindMaze, a  global leader in digital neurotherapeutics, has a product portfolio that has received three FDA clearances and four CE marks across eight clinical indications. This financing will be used to expand its neuro-restorative  portfolio through further system development and clinical trials for several neurological disorders including acute stroke, Parkinson disease, Alzheimer disease, traumatic brain injury, multiple sclerosis and aging.
Click here for more on mergers, acquisition and business news
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
Sohini Dutta, PhD
MedNess Plus
BioPharma News
Rinki Saha
BioPharma News
Managing Editor
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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