On November 30, 2021 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer and other women’s cancers (Press release, Olema Oncology, NOV 30, 2021, View Source [SID1234596273]). Data as of October 1, 2021, is scheduled to be presented in a poster presentation at the San Antonio Breast Cancer Symposium (SABCS), taking place December 7-10, 2021. Updated data as of November 1, 2021, are detailed below.

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These initial data provide strong proof-of-concept for OP-1250 as a once-daily oral monotherapy in women with recurrent, locally advanced or metastatic ER+ / HER2- breast cancer and demonstrate OP-1250’s potential to become a best-in-class endocrine therapy. In the trial, OP-1250 showed highly attractive pharmacokinetics supporting once-daily dosing, favorable tolerability, and clear evidence of anti-tumor activity. Three partial responses (2 confirmed, 1 unconfirmed) and robust target lesion reduction up to 100% were observed in a heavily pretreated patient population. In the recommended Phase 2 dose (RP2D) range of 60-120 mg OP-1250 once daily, the overall response rate (ORR) was 17% and the clinical benefit rate (CBR) was 46%.

"We successfully delivered on our objectives for the dose-escalation stage of our ongoing Phase 1/2 trial of OP-1250, with the desired pharmacokinetics, favorable tolerability, and early but clear efficacy signals. We are particularly encouraged by the responses observed in patients who had received multiple prior lines of therapy and harbored ESR1 activating mutations, demonstrating that OP-1250 is an active drug and achieved sufficient exposure levels to block the ER-mediated cancer cell growth and proliferation signal," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "These data give us confidence to rapidly advance our development program in both monotherapy and combination settings, as we work to further position OP-1250 as a differentiated, potential best-in-class CERAN that we believe could become the backbone endocrine therapy of choice for ER+ breast cancer."

"These promising interim data suggest OP-1250 may provide meaningful benefit to patients with advanced or metastatic breast cancer, and who may have limited treatment options remaining," said Pamela M. Klein, M.D., Chief Medical Officer. "Having accomplished our intended goals with the completed Phase 1 dose escalation, we are currently enrolling patients in dose expansion at two dose levels and expect to initiate Phase 2 monotherapy and the first combination study with a CDK4/6 inhibitor in the first quarter of 2022. As we accelerate enrollment in the coming months, we look forward to gaining additional insights into OP-1250’s potentially differentiated and best-in-class profile."

Interim Results from Phase 1a Dose Escalation of OP-1250 as a Monotherapy

Pharmacokinetics (PK), safety, tolerability, and anti-tumor activity of once-daily OP-1250 monotherapy were evaluated in the open-label, dose-escalation portion of the ongoing Phase 1/2 clinical trial (NCT04505826). As of November 1, 2021, a total of 41 patients with recurrent, locally advanced or metastatic ER+ / HER2- breast cancer were enrolled across 7 dose cohorts (30 mg, 60 mg, 90 mg, 120 mg, 150 mg, 210 mg, and 300 mg once-daily).

This was a difficult-to-treat, heavily pretreated population: 95% of patients were previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor (9 patients, or 22%, received 2 or more prior CDK4/6 inhibitor regimens), 68% of patients received prior fulvestrant, and 42% received prior chemotherapy in the advanced setting. Overall, patients received a median of 3 prior lines of anti-cancer therapy and 2 prior lines of endocrine therapy in advanced settings. Of 39 patients whose circulating tumor DNA (ctDNA) was assessed, ESR1 mutations were detected in 49% at baseline.

PK

Pharmacokinetic analyses demonstrated dose-proportional increases in OP-1250 exposures across all evaluated doses, high oral bioavailability and steady-state plasma levels with minimal peak-to-trough variability. At doses 60 mg and above, OP-1250 achieved exposures exceeding the predicted thresholds for maximal anti-tumor efficacy based on preclinical models.

Tolerability

OP-1250 was generally well tolerated, and no dose-limiting toxicities were reported at any of the seven dose levels studied. A maximum tolerated dose was not reached. The majority of reported adverse events were grade 1 or 2 at all dose levels, and the most common treatment-related adverse events as assessed by study investigator were nausea (49%), fatigue (34%), vomiting (22%) and headache (17%). No clinically significant bradycardia, ocular toxicities or diarrhea occurred. A RP2D range of 60 to 120 mg was identified for further evaluation based on pharmacokinetics, favorable tolerability, and initial evidence of anti-tumor efficacy.

Efficacy

Three partial responses were observed among 24 efficacy-evaluable patients, including 2 confirmed partial responses and 1 unconfirmed partial response in a patient with robust target lesion reduction of 100%, but whose response remained unconfirmed due to progressive disease with a new lesion appearing at a follow-up visit. All 3 responses occurred in patients with ESR1 mutations and who had previously received CDK4/6 and aromatase inhibitors, and fulvestrant. Four response-eligible patients had target lesion reductions of greater than 30%.

Patients were considered efficacy-evaluable for ORR if they had RECIST-measurable disease at baseline and at least one post-baseline tumor assessment or discontinued treatment prior to their first post-baseline assessment, and for CBR if they were enrolled at least 24 weeks prior to the data cut-off date. Across all doses, the ORR was 8% (2/24) and the CBR was 29% (7/24). For the dose levels within the RP2D range, the ORR was 17% (2/12) and the CBR was 46% (6/13).

As of the data cut-off date, 32% of patients (13/41) remained on treatment with efficacy data continuing to mature, including both patients with confirmed partial responses.

Anticipated Milestones

Based on these promising data, Olema is rapidly advancing OP-1250’s clinical development program with a number of anticipated program milestones. Phase 1b dose expansion is ongoing at two dose levels (60 mg and 120 mg daily) and is expected to enroll 15 patients in each cohort. Findings from this stage will help inform selection of the RP2D.

Phase 2 efficacy evaluation is expected to initiate in Q1 2022 with approximately 80 patients enrolled across three cohorts: patients with measurable disease (n=50), patients with non-measurable disease (n=15), and patients with CNS metastasis (n=15). The first Phase 1b combination study with a CDK4/6 inhibitor is expected to initiate in Q1 2022, with additional combination studies with CDK4/6 and PIK3CA inhibitors planned in 2022. A pivotal study for OP-1250 in the metastatic setting is expected to initiate in 2023.

Conference Call and Webcast Details

Olema will host a conference call and webcast presentation for analysts and investors on Tuesday, November 30, 2021, at 8:30 a.m. ET (5:30 a.m. PT) to review the Phase 1 clinical data for OP-1250. The webcast player and accompanying slides may be accessed on the Investors section of Olema’s website at www.olema.com. The conference call may be accessed by dialing +1 (833) 303-1210 for U.S. callers and +1 (918) 922-6526 for international callers and providing the passcode 7627078. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Olema’s website.

About Breast Cancer

Breast cancer is the second-most common cancer worldwide, with nearly two million new diagnoses per year. In the U.S., breast cancer represents approximately 30% of all new diagnoses of women’s cancer. In 2021, the American Cancer Society estimates there will be approximately 281,550 new cases of invasive breast cancer diagnosed in women, and more than 43,600 women will die from breast cancer in the U.S. The estrogen receptor plays an important role in the development, progression, and treatment of hormone-dependent breast cancer. Approximately 75% of all breast cancers are ER+, and approximately 65% are ER+, HER2-.

On November 30, 2021 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 and other major diseases, and Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the novel drug olverembatinib has been approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test (Press release, Innovent Biologics, NOV 30, 2021, View Source [SID1234596293]). Olverembatinib is the sixth approved product and the second approved small-molecule drug of Innovent.

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Olverembatinib is a potentially best-in-class drug that developed by Ascentage Pharma and supported by the major new drug project of the Ministry of Science and Technology. Innovent and Ascentage will be mutually committed to the commercialization of olverembatinib in China market. As China’s first third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval addresses an important unmet treatment need in T315I-mutant CML, bringing benefits for more patients and their families.

This approval for olverembatinib is based on the results from two pivotal Phase II studies – the HQP1351CC201 study and the HQP1351CC202 study. These results showed that olverembatinib is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and deepness of clinical response is expected to increase with prolonged treatment period.

CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for an effective treatment.

The leading principal investigator of olverembatinib in China, Prof. Xiaojun Huang, MD, Director of the Institute of Hematology, Peking University, Director of the Hematology Department at Peking University People’s Hospital, commented: "Efficacy and safety data from studies to date have consistently showed that olverembatinib has enormous potential in effectively addressing the unmet medical need in the treatment of chronic myeloid leukemia, and is a drug with best-in-class potential. The clinical progress with this novel therapeutic has also received widespread interest from the global hematology community over the years. I am excited that olverembatinib is now approved in China, as it finally brings about a breakthrough to the clinical conundrum caused by drug-resistance and a milestone in the treatment of CML. In a broad sense, this approval also signifies that China is rapidly emerging as an important player in hematology clinical development in the global landscape."

The principal investigator of olverembatinib in China, Prof. Qian Jiang, MD, Deputy Director of the Hematology Department at Peking University People’s Hospital, noted: "First- and second-generation TKIs are ineffective in patients with T315I-mutant CML-CP and CML-AP, and drug-resistant CML has been long presented as an urgent unmet clinical need. This approval for olverembatinib bears great significance for doctors and patients, offering a breakthrough to the CML treatment landscape. I am convinced that the approval of olverembatinib will bring new hope to adult patients with CML."

Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, stated: "We are pleased about the NDA approval of olverembatinib in China, which further strengthens Innovent’s franchise in oncology and hematology area by adding a new generation anti-cancer therapy to our commercial portfolio. In oncology area, Innovent has a robust pipeline of up to 20 assets, an industry-leading product development team, and a broad channel coverage with a commercial team of nearly 3000 people. We look forward to collaborating with Ascentage Pharma for the co-commercialization of olverembatinib, in order to bring forth this novel drug to solve the unmet medical needs from Chinese TKI-resistant T315I-mutated CML patients as early as possible."

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said: "This approval for olverembatinib, Ascentage Pharma’s first product entering commercialization, marks a very encouraging milestone in our transition from a R&D-driven biotech into a full-fledged biopharmaceutical company with a commercialized product. At present, we are collaborating with Innovent to go full steam ahead to the buildout of the commercial infrastructure for olverembatinib, Meanwhile, we are partnering with key stakeholders such as genetic testing companies, commercial insurance companies, and online pharmacies, in order to bring this global-leading China-developed novel therapy to patients as soon as possible. We are honored about our commitment to global innovation and our mission of addressing unmet clinical needs in China and around the world. Moving forward, we will continue to explore additional indications of this drug, advance its clinical development overseas, and accelerate the global development of other drug candidates in our pipeline to further solidify our global presence. "

About Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) is a malignancy caused by the clonal proliferation of hematopoietic stem cell in the bone marrow. Also referred to as chronic myelocytic leukemia, CML is one of the most common subtypes of chronic leukemia, accounting for 15% of all leukemia cases in adults. According to epidemiology data, the onset of CML in Chinese patients happens at a younger age than that in the West; the median age of onset of CML in China is around 45 – 50 years old, while it is 67 years old in the West.

BCR-ABL tyrosine kinase inhibitors (TKIs) have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, therefore the mutation had long been a clinical obstacle undermining patients’ long-term survival.

About Olverembatinib

Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, the orally active, third-generation BCR-ABL inhibitor olverembatinib is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant chronic myeloid leukemia (CML). Olverembatinib can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.

In October 2020, olverembatinib was granted the Priority Review status by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients resistant to TKIs and with T315I-mutant chronic phase CML (CML-CP) and accelerated phase CML (CML-AP). In March 2021, it was granted the Breakthrough Therapy designation by the CDE. In overseas, olverembatinib was cleared by the US FDA in July 2019 to directly enter a Phase Ib study. In May 2020, olverembatinib was sequentially granted an Orphan Drug designation and Fast Track designation by the US FDA. In November 2021, olverembatinib was granted an Orphan Designation by the European Union. Furthermore, since 2018, the clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings for four consecutive years, and was nominated for "Best of ASH (Free ASH Whitepaper)" in 2019.

In July 2021, Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

*Olverembatinib has not been approved for any indication in the U.S.

Results from the two pivotal Phase II studies

1) The HQP1351CC201 study in patients with CML-CP

HQP1351CC201 is an open-label, multicenter, single-arm Phase II designed to evaluate the safety and efficacy of patients with T315I-mutant CML-CP who have received prior treatment with BCR-ABL1 TKIs. The primary endpoint of the study is major cytogenetic response (MCyR).

As of data cut-off date of August 25, 2020, the median duration of follow-up in patients with CML-CP was 13.0 months (range: 7.2-16.3). Of the 31 patients evaluable for hematologic responses, all 31 (100%) patients achieved a complete hematologic response (CHR); In the 41 patients evaluable for cytogenetic responses, 31 (75.6%) patients achieved a MCyR, including 28 (68.3%) with complete cytogenetic response (CCyR), and 3 (7.3%) with partial cytogenetic response (PCyR); Among the 41 patients evaluable for molecular responses, 23 (56.1%) achieved a major molecular response (MMR). The 12-month progression-free survival (PFS) was 85.7% (95% CI: [63.6%-94.9%]) and the overall survival (OS) was 100% (95% CI: [100.0% -100.0%].

2) The HQP1351CC202 study in patients with CML-AP

HQP1351CC202 is an open-label, multicenter, single-arm Phase II designed to evaluate the safety and efficacy of patients with T315I-mutant CML-AP and resistance to TKIs developed on prior treatment with BCR-ABL1 TKIs. The primary endpoint of the study is major hematologic response (MaHR).

As of data cut-off date of July 27, 2020, the median duration of follow-up in patients with CML-AP was 14.3 months (range: 6.6-15.2). Of the 17 patients evaluable for hematologic responses, 12 (70.6%) patients achieved a major hematologic response (MaHR), including 11 (64.7%) with CHR and 1 (5.9%) with no evidence of leukemia (NEL); Among the 17 evaluable patients, 8 (47.1%) achieved a MCyR, all of whom achieved (47.1%) a CCyR, and another 7 (41.2%) achieved MMR. The 12-month PFS was 73.3% (95% CI: [43.3%-89.1%]), and the 12-month OS was 88.2% (95% CI: [60.6%-96.9%].

On November 30, 2021 QSAM Biosciences, Inc. (the "Company"), through its wholly-owned subsidiary, QSAM Therapeutics Inc. (the "Subsidiary"),reported that it entered into a patent and technology license agreement (the "License Agreement") and trademark assignment with IGL Pharma, Inc. ("IGL") to secure the exclusive, worldwide rights to the radiopharmaceutical drug candidate, CycloSam (Filing, 8-K, QSAM Biosciences, NOV 30, 2021, View Source [SID1234596310]). The License Agreement stipulated milestone-based payments to IGL tied to successful completion of clinical trial phases, royalty fees on net sales, and commissions from sublicensing or sale of the product among other things. On November 24, 2021, the Company and IGL entered into a first amendment to the License Agreement to effect certain changes to the commercial arrangement between the parties. We have summarized the key terms of the amendment below (the "Amended License Agreement"):

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(i)The Company had previously agreed to issue a 5% equity interest in the Subsidiary to IGL upon satisfaction of certain conditions. Pursuant to the Amended License Agreement, we have agreed to issue 500,000 restricted common shares of the Company to IGL in lieu of equity interest in the Subsidiary;
(ii)The License Agreement stipulated a payment to IGL of up to 50% of any sublicense fees received by the Company in the event of a grant of rights to CycloSam to a third party. This fee has been materially reduced to a fixed payment of 5% of any sublicense fee, which includes the sale of the technology or sale of our Subsidiary that holds the Amended License Agreement to a third party;
(iii)Milestone payments tied to phases of clinical trials were increased from a total of $150,000 to a total of $410,000, which are expected to be paid over the following two to three years, and our payment upon the first commercial sale of CycloSam to third parties was increased from $1,500,000 to $2,000,000;
(iv)We have agreed to provide IGL the right to observe and participate in any board of directors meeting of the Company in which any scheduled agenda item may reasonably affect the rights of IGL under the Amended License Agreement

On November 30, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the U.S. Food and Drug Administration (FDA) has notified the Company that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, TG Therapeutics, NOV 30, 2021, View Source [SID1234596254]).

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Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "We appreciate the FDA’s efforts in reviewing the U2 BLA/sNDA and its interest in obtaining the perspective of the ODAC regarding the benefit-risk of UKONIQ and the U2 combination. We believe UKONIQ is a unique PI3K inhibitor, with a differentiated toxicity and tolerability profile and believe the data submitted thus far are supportive of approval of U2 in CLL."

Mr. Weiss continued, "We look forward to the ODAC meeting as we believe it will provide us an opportunity to highlight the important role U2 can play in the treatment of CLL. As we have noted previously, while many patients with CLL are well-served with currently available therapies, there exists an underserved population, which for a variety of reasons, including tolerability concerns, access issues, and treatment failure, would benefit from an alternative treatment option."

ABOUT THE ODAC MEETING
In general, the ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the FDA will consider the recommendation of the ODAC Committee, the final decision regarding the approval of a product is made solely by the FDA.

The FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed. The FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.

Overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol but was not part of the primary analysis in accordance with the study’s statistical analysis plan agreed upon via a Special Protocol Assessment (SPA), and therefore, was not analyzed or included in the BLA/sNDA. Additionally, the study was not powered for overall survival. As part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of overall survival from the UNITY-CLL trial. As of September 2021, the cut-off date for the overall survival analysis requested by the FDA during their review, there was an imbalance in favor of the control arm (HR: 1.23) though this result was not statistically significant. However, when excluding deaths related to COVID-19, the two arms were approximately balanced (HR: 1.04) with again no statistically significant difference between the treatment groups with regard to overall survival. The overall survival results are preliminary and the Company will continue to evaluate this endpoint over time as more events are available and will continue to analyze how COVID-19 may be impacting the analysis.

The date of the ODAC meeting has not yet been determined, although the FDA has stated that it is targeting holding the ODAC in March or April 2022. Given this timing, we believe it is unlikely that the FDA will make a decision on the BLA/sNDA by the PDUFA goal date of March 25, 2022.

ABOUT UNITY-CLL PHASE 3 TRIAL AND THE BLA/sNDA SUBMISSION
UNITY-CLL is a global, Phase 3, randomized, controlled clinical trial comparing the combination of ublituximab plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, UKONIQ single agent, ublituximab plus UKONIQ, and an active control arm of obinutuzumab plus chlorambucil. A prespecified interim analysis was conducted to assess the contribution of ublituximab and UKONIQ in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm. The trial met its primary endpoint, with U2 significantly prolonging independent review committee (IRC) assessed PFS vs. control (median 31.9 months vs 17.9 months; hazard ratio 0.546 (p<0.0001)) at a median follow-up of 36.7 months, and results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

The BLA/sNDA submissions of U2 to treat CLL were based on the results of the UNITY-CLL trial. The FDA previously granted Fast Track designation to the U2 combination for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL. On May 25, 2021, FDA accepted the BLA for U2 as a treatment for patients with CLL and SLL and set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022.

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. It is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States in 2020 and approximately 45,000 new cases globally in 2020.1,2 Although signs and symptoms of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

CONFERENCE CALL INFORMATION
The Company will host a conference call today, November 30, 2021, at 8:30 AM ET, to discuss the regulatory updates.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

On November 30, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will participate in the JMP Securities Hematology and Oncology Summit, a virtual presentation is scheduled for Tuesday, December 7, 2021 at 2:40 p.m. ET / 11:40 a.m. PT (Press release, Spectrum Pharmaceuticals, NOV 30, 2021, View Source [SID1234596274]).

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A live webcast of the presentation will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after the event.