{"id":57035,"date":"2022-04-14T12:35:58","date_gmt":"2022-04-14T12:35:58","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=90091"},"modified":"2022-04-14T12:35:58","modified_gmt":"2022-04-14T12:35:58","slug":"junshi-biosciences-and-coherus-announce-pd-1-inhibitor-toripalimab-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-the-united-states","status":"publish","type":"post","link":"https:\/\/malaysiantribune.com\/junshi-biosciences-and-coherus-announce-pd-1-inhibitor-toripalimab-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-the-united-states\/","title":{"rendered":"Junshi Biosciences and Coherus Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States"},"content":{"rendered":"
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SHANGHAI, China and REDWOOD CITY, Calif., April 14, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc.\u00a0(\u201cCoherus\u201d) announced today that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (\u201cODD\u201d) for toripalimab, a PD-1 inhibitor, for the treatment of small cell lung cancer (\u201cSCLC\u201d). ODD is granted to drugs intended to treat rare diseases with a patient population less than 200,000 in the United States. The designation provides incentives to advance development and commercialization of drugs that have the potential to provide benefit to patients with rare diseases.<\/p>\n

SCLC is an aggressive tumor characterized by rapid disease progression, low expression of PD-L1 and low levels of tumor infiltrating immune cells, as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in SCLC. No PD-1 inhibitors are currently approved in the United States for SCLC. Prognosis for SCLC patients is poor, with five year survival rates of approximately 20% and less than 5% for patients with extensive stage SCLC.<\/p>\n

The JUPITER-08 study (NCT04012606) is an ongoing, randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial evaluating PD-1 inhibitor toripalimab in combination with chemotherapy (cisplatin or carboplatin + etoposide) compared to placebo in combination with chemotherapy as the first-line treatment of extensive stage SCLC. Enrollment in this trial has been completed. The co-primary endpoints of the study are overall survival and progression free survival as assessed by the investigator.<\/p>\n

\u201cLung cancer is the second most prevalent malignant tumor and has the highest mortality rate. However, there is a disparity in the development of new treatments for different subtypes of lung cancer, non-small cell lung cancer (\u201cNSCLC\u201d) and SCLC. For NSCLC without oncogenic mutations, multiple immuno-oncology drugs, including toripalimab, have been shown to improve survival when added to chemotherapy as compared to chemotherapy alone, whereas treatment options for SCLC patients are limited to chemotherapy with one of two PD-L1 inhibitors,\u201d said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. \u201cWe appreciate the FDA\u2019s recognition of our endeavors to develop new therapies for SCLC patients and, based on experience in other cancers, are hopeful that toripalimab may provide a significant advance over chemotherapy in the JUPITER-08 study.\u201d<\/p>\n

\u201cToripalimab in combination with chemotherapy has demonstrated robust antitumor immunity and survival benefit in multiple tumor types including in tumors with low PD-L1 expression. This differentiated clinical activity may result from toripalimab\u2019s unique binding epitope and internalization properties,\u201d said Dr. Theresa LaVallee, Chief Development Officer at Coherus. \u201cSCLC patients have a particularly poor prognosis, and new and better treatment options are clearly needed for patients with this aggressive cancer. We are pleased to be working closely with our partner, Junshi Biosciences, to evaluate toripalimab in this underserved patient population and look forward to topline data from the pivotal first line SCLC clinical trial expected later this year.\u201d<\/p>\n

About toripalimab <\/strong>
\nToripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system\u2019s ability to attack and kill tumor cells.<\/p>\n

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in\u00a0China, the\u00a0United States,\u00a0Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.<\/p>\n

In\u00a0China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in\u00a0China\u00a0as TUOYI\u00ae). Currently, there are four approved indications for toripalimab in\u00a0China:<\/p>\n

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  1. unresectable or metastatic melanoma after failure of standard systemic therapy;<\/li>\n
  2. recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;<\/li>\n
  3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;<\/li>\n
  4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.<\/li>\n<\/ol>\n

    The first three indications have been included in the National Reimbursement Drug List (\u201cNRDL\u201d) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.<\/p>\n

    In addition, two supplemental New Drug Applications (\u201cNDAs\u201d) for toripalimab are currently under review by the\u00a0National Medical Products Administration\u00a0(\u201cNMPA\u201d) in\u00a0China:<\/p>\n