Benzinga | Apr 23, 2021 10:32AM EDT

AnaptysBio Reports European Commission Has Approved JEMPERLI For Recurrent or Advanced dMMR/MSI-H Endometrial Cancer in Europe

* PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in Collaboration with GlaxoSmithKline (GSK)

* First AnaptysBio-Generated Antibody, of 8 Currently Under Clinical Development, to Obtain Regulatory Approval in Europe

* $10MM Milestone Payment Earned by AnaptysBio Upon EC Approval; Additional $35MM and $165MM Milestones Due Upon Dostarlimab Regulatory and Commercial Milestones, Respectively

* AnaptysBio Due to Receive 8% to 25% Royalty on Global Net Sales of Dostarlimab

SAN DIEGO, April 23, 2021 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that the European Commission has granted conditional marketing authorization for JEMPERLI (dostarlimab) for use in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe.

JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date, and JEMPERLI is the first AnaptysBio-generated antibody to obtain regulatory approval.

"We are delighted that JEMPERLI is the first AnaptysBio-generated antibody to be approved in Europe and look forward to meaningful potential future milestone and royalty revenue from our collaboration with GSK," said Hamza Suria, president and chief executive officer of AnaptysBio. "These revenues will continue to support AnaptysBio's primary value-creation strategy, which is focused on advancing wholly-owned first-in-class therapeutic antibodies through multiple upcoming clinical catalysts in 2021 and 2022."

JEMPERLI is indicated as a monotherapy for treatment of adult patients with recurrent or advanced dMMR/MSI-H endometrial cancer, who have progressed on, or are being dosed following, prior treatment with a platinum-containing regimen, and is the first indication approved by the European Commission for JEMPERLI. AnaptysBio has earned a $10.0 million milestone payment as a result of this approval. Earlier this month, AnaptysBio earned a $20.0 million milestone payment as a result of approval by the U.S. Food and Drug Administration for JEMPERLI in endometrial cancer. In 2020, AnaptysBio received milestone payments of $10.0 million and $5.0 million for the FDA's and EMA's acceptances of the BLA and Marketing Authorisation Application (MAA) filings for JEMPERLI, respectively.

Earlier this year, FDA accepted a subsequent BLA filing for JEMPERLI for the treatment of adult patients with dMMR recurrent or advanced solid tumors who have progressed on or following prior treatment. AnaptysBio recently received a $10.0 million payment from GSK as a result of this milestone. Payments totaling an additional $35 million will be due to AnaptysBio upon the achievement of future regulatory milestones for JEMPERLI in the United States and Europe. Furthermore, $165 million in sales milestones are due to AnaptysBio upon achievement of certain annual JEMPERLI net sales revenues. Royalties due to AnaptysBio for dostarlimab range from 8% to 25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. JEMPERLI is also being developed by GSK for the treatment of other tumor types and treatment settings, including currently ongoing phase III trials in recurrent or primary advanced endometrial cancer in combination with chemotherapy standard of care (RUBY) and the phase III FIRST study of platinum-based therapy with dostarlimab and niraparib versus standard of care platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer.

In addition, JEMPERLI is being evaluated as monotherapy and in combination therapy across multiple tumor types and other cancers, including platinum-resistant ovarian cancer, non-small cell lung cancer, multiple myeloma and melanoma.

GSK continues to develop additional antibodies partnered with AnaptysBio, including cobolimab, an AnaptysBio-generated anti-TIM-3 antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist antibody. Under the terms of the collaboration, AnaptysBio is due to receive development and regulatory milestone payments for each of the first two indications for each of these antibodies. AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this collaboration. In addition, AnaptysBio will receive royalties ranging from 4% to 8% on global net sales of cobolimab and GSK4074386 and 1% of GSK's global net sales of ZEJULATM.

Important Information for JEMPERLI in the EU

Indication

JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.

Immune-Mediated Adverse Reactions

Immune-related adverse reactions, which may be severe or fatal, can occur in patients treated with antibodies blocking the programmed cell death protein-1 / programmed death-ligand 1 (PD-1/PD-L1) pathway, including JEMPERLI. While immune-related adverse reactions usually occur during treatment with PD-1/PD-L1 blocking antibodies, symptoms can also manifest after discontinuation of treatment. Immune-related adverse reactions may occur in any organ or tissue and may affect more than one body system simultaneously. Important immune-related adverse reactions listed in this section are not inclusive of all possible severe and fatal immune-related reactions.

Early identification and management of immune-related adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Patients should be monitored for symptoms and signs of immune-related adverse reactions. Clinical chemistries, including liver tests and thyroid function tests, should be evaluated at baseline and periodically during treatment. For suspected immune-related adverse reactions, adequate evaluation including specialty consultation should be ensured.

Based on the severity of the adverse reaction, treatment with JEMPERLI should be withheld or permanently discontinued and corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy administered. Upon improvement to Grade ?1, corticosteroid taper should be initiated and continued for 1 month or longer. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Hormone replacement therapy for endocrinopathies should be instituted as warranted.

Treatment with JEMPERLI should be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones and unless otherwise specified in the Summary of Product Characteristics (SmPC).