On May 8, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, "BlissBio"), for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration (Press release, Eisai, MAY 7, 2023, View Source [SID1234631139]).

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BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express HER2. The linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by Eisai’s U.S. research base Exton Site, and Eisai is investigating the possibilities of using this platform to link to various antibodies. Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload. Based on the status of the Phase I/II clinical trials of BB-1701 currently being conducted by BlissBio, the both companies have decided to co-develop this drug.

Under the terms of the joint development agreement, Eisai will make upfront and development milestone payments to BlissBio, conduct a Phase II clinical trial in breast cancer, and obtain option rights to develop and commercialize BB-1701 globally, excluding Greater China (China, Hong Kong, Macau, Taiwan). If Eisai exercises the option rights, an additional upfront payment will be made to BlissBio, as well as development and regulatory milestone payments, sales milestone payments and a certain amount of royalties on sales revenue of BB-1701 after the launch. If all development, regulatory and sales milestones are achieved, up to a total of $2 billion USD will be paid.

"BB-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "Our collaboration with BlissBio will accelerate the development of BB-1701 with the goal of bringing a new treatment option to patients globally."

On May 7, 2023 Independent biopharmaceutical company Specialised Therapeutics Asia (ST) reported that a new therapy to treat rare gastrointestinal stromal tumours (GIST) shown to improve survival has been approved for use in Singapore (Press release, Specialised Therapeutics Asia, MAY 7, 2023, View Source [SID1234631114]).

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The therapy, QINLOCK (ripretinib) is now approved by the Health Sciences Authority (HSA) "for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib, sunitinib, and regorafenib".

Singapore-based senior consultant in medical oncology Dr Richard Quek said QINLOCK represented a major treatment advancement for patients with advanced GIST.

"Since 2013, despite multiple attempts and studies, no therapy was shown to be effective for 4th line GIST patients whose cancers have progressed on existing treatment, until the discovery of QINLOCK," Dr Quek said.

In the pivotal INVICTUS study that led to QINLOCK’s approval, QINLOCK was shown to significantly delay cancer progression.

"This approval in Singapore clearly provides an opportunity for us to improve the outcomes of our GIST patients who are refractory to the current existing treatment."

QINLOCK is an oral medication used to treat GIST in people who have received at least three prior treatments. It belongs to a drug class called tyrosine kinase inhibitors and works by blocking specific tumour proliferation pathways.2

A pivotal Phase 3 clinical trial of QINLOCK – the INVICTUS study – demonstrated that QINLOCK was able to significantly reduce the risk of disease progression by 85% (hazard ratio of 0.15, p<0.0001) with a median progression-free survival of 6.3 months in patients administered QINLOCK, compared to 1.0 month in the placebo arm.1 QINLOCK was associated with clinically meaningful overall survival of 15.1 months vs 6.6 months and reduced the risk of death by 64% (hazard ratio of 0.36). The objective response rate by Blinded Independent Central Review using modified Response Evaluation Criteria in Solid Tumors (RECIST) was 9.4% with QINLOCK vs 0.0% with placebo (p=0.0504).1,3

In addition, in a long-term follow up analysis of the INVICTUS trial, patients in the QINLOCK arm demonstrated a median overall survival of 18.2 months compared to 6.3 months in the placebo arm and reduced the risk of death by 59% (hazard ratio of 0.41).The objective response rate was 11.8% with QINLOCK vs 0.0% with placebo.3

ST Chief Executive Officer Carlo Montagner said the Singapore approval followed the recent approval of QINLOCK in New Zealand, as well as regulatory and reimbursement approval in Australia.

"Achieving these critical regulatory milestones is testament to the dedication of our regulatory teams to make QINLOCK available to all eligible patients in Singapore who are impacted by this rare gastrointestinal cancer."

ST commercialises QINLOCK in Singapore under an exclusive distribution agreement from US based Deciphera Pharmaceuticals.

Further Inquiries can be directed to ST Senior Manager Communications and Corporate Affairs Emma Power on + 65 31589910 [email protected]

About GIST

Gastrointestinal stromal tumour (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST growth usually begins in the connective tissue in the wall of the affected organ and grows outwards. The common location of GIST is in the stomach (50 to 60%) and small intestines (30 to 40%) but can occur in any site in the digestive system. Other possible GIST sites are the oesophagus, rectum, and colon. GIST cases are rare and estimated to cause between 0.1% and 3% of GI cancer. The risk of GIST diagnosis increases with age, with GIST incidence peaking among people in their fifties and sixties.4

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

On May 7, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has entered into an agreement with Bayer AG (Bayer) to supply Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906) (Press release, Telix Pharmaceuticals, MAY 7, 2023, View Source [SID1234631113]). This global study is investigating the efficacy of Bayer’s androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline.

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The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.

Telix Chief Medical Officer, Dr Colin Hayward stated, "We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix’s unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool."

On May 7, 2023 Bliss Biopharmaceutical (Hangzhou) Co., Ltd, ("BlissBio") a clinical-stage biopharmaceutical company developing differentiated antibody-drug conjugate (ADC) therapeutics, reported a clinical trial collaboration agreement with option for strategic collaboration with Eisai Co., Ltd. ("Eisai"), for BB-1701, eribulin-payload based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2) for the treatment of cancers (Press release, Bliss Biopharmaceutical, MAY 7, 2023, View Source [SID1234631112]).

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This collaboration with Eisai is an important advancement in BlissBio’s corporate development plan to further develop BB-1701 globally and help advance BB-1701 toward late stage of development. BB-1701 is currently in Phase I/II studies in the US and China with over one hundred patients dosed in various types of cancers.

Under the terms of the agreement, BlissBio will receive upfront and milestone payments, and BlissBio and Eisai will conduct co-development activities related to BB-1701 through an option period. Upon Eisai’s exercise of its option to enter into a strategic collaboration license of BB-1701, BlissBio will receive an option exercise payment and be eligible for development and commercial milestone payments up to an aggregate of $2 billion, as well as royalties on sales. Upon the exercise of the option, Eisai will receive worldwide (excluding Greater China) rights to develop and commercialize BB-1701.

"This clinical collaboration with Eisai, one of a leading Japanese pharmaceutical company with strong oncology R&D capability worldwide, is a significant accomplishment for BlissBio, as it allows us to further develop this promising compound, BB-1701", stated Dr. Ziping Wei, Chief Executive Officer of BlissBio. "Through this important partnership we will commit to working with Eisai to advance the development of BB-1701 for the benefit of patients worldwide."

About BB-1701

BB-1701 is an innovative ADC developed by BlissBio consisting of anti-HER2 antibody and eribulin. It is designed to provide a safer and more effective treatment regimen for patients with locally advanced/metastatic HER2 expressing solid tumors and expected to have multiple market prospects for application in various tumor indications. BB-1701 has unique mechanism of action (MOA) including potent bystander effect and immunogenic cell death (ICD) activity. BB-1701 is conducting Phase I/II international clinical trials both in China and US.

On May 7, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that second interim analysis and survival analysis results of the ORIENT-31 study (NCT03802240) have been published in the Lancet Respiratory Medicine (https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(23)00135-2/fulltext) (Press release, Innovent Biologics, MAY 7, 2023, View Source [SID1234631111]). This randomized, double-blinded, multi-center Phase 3 study evaluated TYVYT(sintilimab) with or without anti-VEGF antibody therapy (BYVASDA [bevacizumab injection]) combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated non-squamous non-small cell lung-cancer (NSCLC) who progressed after EGFR-TKI therapy. The first interim analysis has been published in the Lancet Oncology in 2022i.

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In the second interim analysis (data cutoff date: March 31th, 2022), the main purpose is to analyze the median progression-free survival (mPFS) of the preset sintilimab plus chemotherapy group (Arm B) versus chemotherapy group (Arm C) in the intent-to-treat (ITT) population, update the results of sintilimab plus bevacizumab plus chemotherapy group (Arm A) and report the overall survival results of the study for the first time. The median follow-up duration of progression-free survival (PFS) were 12.9 months, 15.1 months, and 14.4 months in Arm A, Arm B and Arm C, respectively. Based on the assessment by the Independent Radiographic Review Committee (IRRC), the median PFS were 7.2 months (95%CI: 6.6, 9.3) in Arm A, 5.5 months (95%CI: 4.5, 6.1) in Arm B, and 4.3 months (95%CI: 4.1, 5.3) in Arm C. Arm B demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Arm C, with a HR of 0.72 (95%CI: 0.55, 0.94, P=0.016), which reached pre-specified superiority boundary value. Significant PFS benefit was sustained in Arm A compared to Arm C with a HR of 0.51 (95%CI: 0.39, 0.67, p<0.0001).

As of data cutoff July 4th, 2022, a trend towards overall survival (OS) benefit with Arm A was observed although the median OS for Arm C was prolonged due to crossover after progression in Arm C. The median OS for Arm A and Arm C were 21.1 months vs 19.2 months, HR=0.98. After adjusting for crossover, the OS HR ranged from 0.79 to 0.84. In the exploratory analyses of quality of life, Arm A showed longer median time-to-deterioration of the Global Health Status Dimension Score of EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) compared with Arm C.

The safety results were generally consistent with those in the first interim analysis; in particular, treatment-related adverse events of grade ≥3 were 56% in Arm A, 41% in Arm B and 49% in Arm C. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and bevacizumab, without new or unexpected safety signals.

Globally, ORIENT-31 is the first multi-center, double-blind, prospective Phase 3 study to demonstrate significant PFS benefit of combination therapy of an anti-PD-1 antibody with chemotherapy in patients with EGFR mutated nsqNSCLC that progressed on prior EGFR-TKI therapy. Sintilimab and chemotherapy group showed significant improved PFS with an optimal safety profile. With the extension of follow-up time, sintilimab plus bevacizumab and chemotherapy group continued to show a durable, clinically meaningful PFS benefit.

The principal investigator of the ORIENT-31 Study, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, " ORIENT-31 is globally the first prospective, randomized, double-blind Phase 3 study that demonstrated significant PFS benefit of combination therapy of anti-PD-1 antibody and chemotherapy with or without bevacizumab in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy, which was revolutionary in immunotherapy. I am pleased to witness the first and second interim analysis results of the ORIENT-31 study were published in international authoritative and influential journals. Besides, I hope that the recent approval of sintilimab in combination with bevacizumab and chemotherapy in treatment of patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy can bring a new treatment option benefiting more cancer patients."

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "the ORIENT-31 study is the first Phase 3 study that met primary endpoints in the world evaluating efficacy of PD-1 inhibitor and chemotherapy with or without bevacizumab in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy. The results of first and second interim analysis were published in the Lancet Oncology and the Lancet Respiratory Medicine, respectively. That represents the international academia’s recognition of high quality, innovative clinical trial conducted by investigators in China, and is also a milestone marking Innovent’s solid and outstanding capabilities in new drug development. Meanwhile, we look forward to the approval of sintilimab in combination with bevacizumab and chemotherapy based on the results of the ORIENT-31 study can bring new hope to patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy. Innovent endeavors to advance innovative drug development targeting unmet medical needs, to bring more effective and affordable treatment options to patients in China and the world."