On December 2, 2022 Qilu Pharmaceutical, one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures, and distributes both finished formulations and Active Pharmaceutical Ingredients, reported that the results of the phase II study evaluating QL1706 plus chemotherapy +/- bevacizumab for the treatment of non-small cell lung cancer (NSCLC) were released on 2 December 2022 in poster presentations (325P and 332P) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2022 (Press release, Qilu Pharmaceutical, DEC 2, 2022, View Source;bevacizumab-for-the-treatment-of-non-small-cell-lung-cancer-in-the-phase-ii-study-at-esmo-asia-congress-2022-301692344.html [SID1234624707]).

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QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 antibodies, showing promising antitumor efficacy in advanced solid tumors including NSCLC in a phase I study. This is a phase II, open-label, single-center study of QL1706 plus chemotherapy +/- bevacizumab in patients with advanced NSCLC (NCT05329025). In this study, advanced NSCLC patients with wild-type and mutated epidermal growth factor receptor (EGFR) were enrolled.

As of the data cutoff, 29 patients with advanced NSCLC with wild-type EGFR and naïve to systemic treatment were enrolled to receive QL1706 (5 mg/kg) plus chemotherapy (paclitaxel plus carboplatin or pemetrexed plus carboplatin) once every 3 weeks (Q3W) for 2 cycles and then QL1706 5 mg/kg Q3W for maintenance therapy until disease progression or other discontinuation events. The median follow-up was 9.17 months. The objective response rate (ORR) was 58.6% (squamous NSCLC cohort: 70.6%; non-squamous NSCLC cohort: 41.7%). The disease control rate (DCR) was 93.1% (27/29). The median progression-free survival (mPFS) was 6.97 months.

A total of 31 patients with advanced NSCLC with mutated EGFR, having disease progression after or not tolerating EGFR tyrosine kinase inhibitors with or without bevacizumab/anlotinib were also enrolled to receive QL1706 (5 mg/kg) plus chemotherapy (pemetrexed plus carboplatin) and bevacizumab Q3W for 4 cycles and then QL1706 5 mg/kg plus pemetrexed and bevacizumab Q3W for maintenance therapy until disease progression or other discontinuation events. The median follow-up was 5.75 months. The ORR was 64.5% (20/31) and DCR was 93.5% (29/31). PFS was not yet mature. The 6-month PFS rate was 61.3%.

Overall, QL1706 plus chemotherapy showed a good safety profile. Adverse events were manageable and the safety profile was consistent with that reported for chemotherapy or anti-PD-1 and anti-CTLA-4 therapy.

Ms. Xiaoyan Kang, Head of Qilu Pharmaceutical clinical research center, stated, "We are pleased to release the latest study results of QL1706 plus chemotherapy +/- bevacizumab for the treatment of advanced NSCLC. Based on results from this study, we are planning several phase III studies of QL1706 for the treatment of NSCLC and we hope to bring a new treatment option to patients with advanced NSCLC in the future."

On December 1, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, reported new data from the OLYMPUS registration trial designed to obtain long-term follow-up data on JELMYTO (mitomycin) for pyelocalyceal solution that shows median durability of response (DOR) of 28.9 months (Press release, UroGen Pharma, DEC 2, 2022, View Source [SID1234624705]). The study (Abstract #158) was presented at SUO on December 1.

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"The clinical benefit of JELMYTO was demonstrated in the Phase 3 OLYMPUS study and data presented today highlighted the long-term durability of that benefit," said Dr. Phillip Pierorazio, M.D., Chief, Section of Urology at Penn Presbyterian Medical Center, Philadelphia, PA. "JELMYTO provides an effective and durable kidney-sparing treatment option and should be considered as primary therapy for adult patients with LG-UTUC."

Patients who completed OLYMPUS were eligible to participate in this rollover study. Outcomes of interest include DOR in patients who remain in complete response (CR) at the end of OLYMPUS, events of disease recurrence and progression, post-study treatments and death.

At the time of data cut off (February 25, 2022), data were available for 16 of 23 patients who had remained in CR at the end of the OLYMPUS study. The median DOR among the 16 patients was 28.9 months (14.6 to 47.6 months). Thirteen patients remained in CR, two patients had recurrence of low-grade upper tract urothelial carcinoma (LG-UTUC) on the same side as treated in OLYMPUS, and one patient underwent radical nephroureterectomy (RNU) due to ureteral stricture without evidence of UTUC at the time of surgery. No patient had progressed to high-grade disease.

"JELMYTO is an important addition to the urologist’s tool kit for treating LG-UTUC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "These data are the first to show the potential for long-term recurrence free survival in patients treated with JELMYTO. We look forward to additional independent validation of this important observation."

About the Pivotal OLYMPUS Study

OLYMPUS (Optimized DeLiverY of Mitomycin for Primary UTUC Study) was an open-label, single-arm Phase 3 clinical study of UGN-101 JELMYTO (mitomycin) for pyelocalyceal solution, to evaluate the safety, tolerability and tumor ablative effect of JELMYTO in patients with LG-UTUC. Seventy-one patients were treated at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of JELMYTO administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine CR, the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer and for cause biopsy. Patients who achieved a CR at the PDE timepoint were eligible for the maintenance phase of the trial, during which they could receive monthly maintenance instillations for up to 12 months and were assessed quarterly to determine the durability of response with JELMYTO.

In the OLYMPUS study, data was generated for the retrograde administration of JELMYTO. In that study population ureteric stenosis was reported in 58% (n=41) of patients receiving JELMYTO, with only 17% (n=12) of patients experiencing a Grade 3 event.

About LG-UTUC

LG-UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the current standard for treatment of high-grade UTUC, it may be over-treatment in LG-UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity.

On December 1, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported the grant of inducement stock options exercisable for 14,400 shares of G1’s common stock and 9,400 restricted stock units (RSUs) to five hired employees under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the "Amended and Restated 2021 Plan") (Press release, G1 Therapeutics, DEC 2, 2022, View Source [SID1234624674]). These equity awards were granted as an inducement material to the new employee’s becoming an employee of G1 in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Amended and Restated 2021 Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of G1 (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with G1, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The stock options are exercisable at a price of $5.85 per share, the closing price of G1’s common stock on December 1, 2022, the grant date. The stock options have up to a ten-year term and vest over four years, with 25% of the award vesting on the first anniversary of the employee’s employment, and as to an additional 1/48th of the shares monthly thereafter, subject to continued service through the applicable vesting dates (subject to the terms and conditions of the stock option agreement covering the grant). The RSUs have a four-year term, with 25% of the award vesting on the first anniversary of the grant date, and the remainder vesting 12.5% semi-annually over the remaining three years, subject to continued service through the applicable vesting dates (subject to the terms and conditions of the RSU agreement covering the grant). The stock options and RSUs are subject to the terms and conditions of the Amended and Restated 2021 Plan.

On December 1, 2022 Optieum Biotechnologies reported that the company has entered into a research collaboration agreement with the National Cancer Center Japan("NCC") to initiate multiple projects to discover and develop innovative CAR-T cell therapy assets targeting solid tumors (Press release, Optieum Biotechnologies, DEC 1, 2022, View Source [SID1234639141]).

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Optieum has a platform technology to elicit functional and improved scFvs that can lead to superior antitumor reactivity of CAR-T cells. NCC, Exploratory Oncology Research and Clinical Trial Center (NCC-EPOC) has expertise in clinical research and development of cancer immunotherapy, and is capable of accelerating translational research by integrating its clinical resources into this collaboration.

With the completion of signing, Optieum and Division of Cancer Immunotherapy (Chief, Dr. Tetsuya Nakatsura) of NCC-EPOC, will begin joint research to develop CAR-T cell therapies for patients with solid tumors.

On December 1, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will host an investor event on December 10 during the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, LA (Press release, Affimed, DEC 1, 2022, View Source [SID1234624722]).

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Investor event information
Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET
Location: New Orleans, LA and virtual
Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies. The investor event will take place in-person and virtually and a webcast of the event will be available in the "Webcasts" section on the "Investors" page of Affimed’s website at View Source
To access the event via phone, please dial +1 (929) 205-6099 for U.S. callers, or +44 (203) 481-5240 for international callers, and reference meeting ID 847 4106 6227 approximately 15 minutes prior to the call.
To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected].
A replay of the webcast/call will be archived on Affimed’s website for 30 days after the call.

About AFM13
AFM13 is a CD30/CD16A bispecific Innate Cell Engager (ICE) that is investigated in Hodgkin Lymphoma (HL) and T cell lymphoma (TCL). AFM13 has shown single agent efficacy in HL and TCL and is currently being evaluated as monotherapy in a single arm registration-directed trial in peripheral TCL (REDIRECT). In addition, AFM13 showed high response rates in combination with the anti-PD-1 antibody Keytruda (ORR: 88%, CR: 46%) and in combination with allogeneic cord blood-derived NK cells (ORR: 100%, CR: 71%). Affimed recently entered into a partnership with Artiva to develop AFM13 in combination with Artiva’s allogeneic, cryopreserved, NK cell product AB-101 in HL and TCL.