On September 10, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, reported a poster at ESMO (Free ESMO Whitepaper) Congress 2022 containing updated efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Point Biopharma, SEP 10, 2022, View Source [SID1234619371]). Key findings include a median rPFS time of 11.5 months, along with a well-tolerated safety profile with no treatment-related deaths and few treatment-related AEs of grade 3 or higher.

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"rPFS is the primary endpoint of the SPLASH trial, making these positive signals from the lead-in cohort extremely promising," said Dr. Neil Fleshner, Chief Medical Officer of POINT Biopharma. "I believe the dosing schedule of four cycles of 177Lu-PNT2002 at 6.8 GBq per cycle every 8 weeks is a unique differentiator offering lower overall whole-body radiation and shorter overall treatment than currently approved PSMA RLT therapies."

The full poster is available to download at the Company’s investor relations website, located at View Source Upcoming third-party coverage of the data will include video interviews of Dr. Fleshner by UroToday, and of Dr. Aaron R. Hansen by VuMedi. Dr. Hansen is Deputy Director for the Division of Cancer Services at Metro South Health, a Medical Oncologist at Princess Alexandra Hospital, and an Associate Professor of Medicine at the University of Toronto and the University of Queensland.

The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with prostate-specific membrane antigen (PSMA)-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy. Compared to other currently approved radioligand therapies for prostate cancer, SPLASH is evaluating PNT2002 earlier in the treatment pathway and using fewer and lower doses. The treatment regimen for the lead-in cohort is the same as the regimen being investigated in the randomization part of the trial: participants receive up to four cycles of 177Lu-PNT2002 at 6.8 GBq per cycle every 8 weeks. The SPLASH trial is currently enrolling patients across 53 sites in North America, Europe, and UK, and site activations remain ongoing to expedite accrual.

The poster is titled "Efficacy and Safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH" (e-Poster #1400P). The poster’s newly released data were based on a median follow-up of 11.7 months, updating the previously published abstract which was based on a median follow-up of 7.6 months. Key findings for the lead-in cohort include:

Median rPFS was 11.5 months, as compared to the control arm benchmarks of 3.5–4.2 months for individuals with progressive mCRPC post-ARPI failure receiving similar treatment1,2
Median overall survival had not been reached with an 11.7-month median duration of follow-up from time of enrollment
A radiographic objective response was achieved in 60% of the 10 participants with evaluable disease at baseline
84.8% of individuals imaged met PSMA eligibility criteria
From a median baseline PSA (ng/mL) of 22 (range 0.3–701.0), 11 (42%) participants achieved a PSA50 response
PNT2002 was well tolerated with no treatment-related deaths and few treatment-related AEs of grade 3 or higher
Treatment-related adverse events occurring in >10% of participants included dry mouth (25.9% of participants; all grade 1), fatigue (22.2%; grades 1-2), nausea (18.5%; grades 1-2), and anaemia (14.8%; grades 1-3)
"In this patient population, which was not as heavily pre-treated as the population studied in the published randomized trials of 177Lu-PSMA-617, PNT2002 was very well tolerated," said Scott Tagawa, MD, MS, FACP, Medical Oncologist at Weill Cornell Medicine, Professor of Medicine at Meyer Cancer Center, SPLASH trial investigator, and senior author on the SPLASH poster at ESMO (Free ESMO Whitepaper). "The early efficacy signals of PSA and measurable disease responses, combined with the favorable, though non-randomized, rPFS data, are encouraging for success of the phase 3 study."

Prior to the publication of the lead-in cohort data, the Company hosted a 45-minute educational webinar on August 18, 2022 entitled "Understanding the PNT2002 SPLASH Trial Control Arm" featuring presentations from Dr. Oliver Sartor and Dr. Kim Chi.

Both the poster and the webinar are available under the Presentations tab of the Investors section of the Company’s website, located at View Source

1. de Bono J, Mateo J, Fizazi K, et al. N Engl J Med 2020;382:2091–102.
2. Powles T, Yuen KC, Gillessen S, et al. Nature 2022;28:144–53.

Potential conflict of interest disclosure: Dr. Tagawa has received research funding and honoraria for consulting from POINT.

About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.

On September 10, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, reported that new clinical data from the ongoing Phase 1/1b trial of BCA101, an EGFR / TGF-b bifunctional antibody, as a monotherapy and in combination with pembrolizumab (Press release, Bicara Therapeutics, SEP 10, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-presents-new-data-from-ongoing-phase-1-1b-trial-of-lead-first-in-class-bifunctional-program-bca101-at-the-european-society-for-medical-oncology-esmo-congress-2022 [SID1234619363]). These data were presented in an oral presentation session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, being held in Paris, France.

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"Seeing durable responses in our patients with head and neck cancer at this early stage of clinical development is very encouraging," said Glenn J. Hanna, M.D., Director of the Center for Salivary and Rare Head and Neck Cancers, Dana-Farber Cancer Institute, and Principal Investigator for the Phase 1/1b clinical trial of BCA101. "BCA101, a first-in-class molecule, may represent a potential new option for our patients. We look forward to continuing enrollment in the dose expansion portion of the study."

"The data presented today underline the significant progress we have made in the last few months to demonstrate the efficacy of BCA101," said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. "We are extremely encouraged by the durable responses we are seeing in heavily pre-treated patients, and by the responses we are seeing in combination with pembrolizumab in a front-line head and neck patient population, enabling us to achieve the first efficacy threshold in dose expansion."

BCA101 Data Highlights:

In the first-line recurrent/metastatic HNSCC dose expansion combination cohort, the four partial responses needed to open Stage 2 have been observed prior to completing Stage 1 enrollment.
BCA101 is well tolerated and clinically active as a single agent and in combination with pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC), squamous cell carcinoma of the anal canal (SCAC) and squamous non-small cell lung cancer (SqNSCLC).
In dose escalation, single-agent activity, including one durable partial response, was observed among late-line patients treated with BCA101. A disease control rate of 58% was observed in evaluable patients at doses above 1000 mg.
In the combination dose escalation arm, a partial response was observed in four out of 13 (31%) evaluable patients (two each in SCAC and HNSCC) as well as a disease control rate of 69%. Patients had a median of four prior lines of therapy prior to entering the BCA101 study.
All four patients with responses have been on study for more than eight months, including one HNSCC patient who was refractory to anti-PD-1 therapy and cetuximab.
BCA101 is currently being evaluated in a Phase 1/1b study as monotherapy and in combination with pembrolizumab as a first-line therapy in patients with unresectable, recurrent or metastatic HNSCC and as second-line therapy in patients with advanced SCAC who have received prior chemotherapy. A third cohort of patients with advanced or incurable cutaneous squamous cell carcinoma who have received previous anti-PD-1 therapy will be treated with BCA101 as monotherapy. Bicara initiated the dose expansion arm of this study in February 2022.

Webcast Details:

Date and time: Monday, September 12, 2022 at 10:30 a.m. ET
To register: Please visit the Online Experiences website to register for the live event. Following the live webcast, an archived replay will be available on the Bicara website.
About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b dose-escalation clinical trial of BCA101 is currently enrolling in front-line HNSCC and additional solid tumors. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

On September 10, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, taking place in Paris, France from September 9-13, 2022 (Press release, Wugen, SEP 10, 2022, View Source [SID1234619362]).

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"We are pleased to present these data and build on the growing body of evidence validating our best-in-class memory NK cell platform," said Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen. "Today’s findings are an important step forward as we continue to advance WU-NK-101 into clinical development for both solid tumors and acute myeloid leukemia (AML)."

"While adoptive cell therapies have proven a powerful tool against hematological cancers, their application to solid tumors has historically been limited by restricted cell trafficking to tumors and the harsh tumor microenvironment (TME)," added Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Professor of Cancer Immunotherapy at Nottingham Trent University and presenting author. "These findings are highly promising and suggest that memory NK cells can circumvent these challenges, with broad potential therapeutic applications for solid tumors."

Today’s presentation highlighted the following:

WU-NK-101 exhibited enhanced metabolic fitness and metabolic flexibility, contributing to resilient and enhanced function within the adverse immunosuppressive TME relative to conventional NK (cNK) cells.
WU-NK-101 showed potent cytotoxicity against tumor cells. In vitro, WU-NK-101 in combination with monoclonal antibodies (mAbs) demonstrated a statistically significant increase in antibody-dependent cellular cytotoxicity (ADCC) activity when compared to mAbs alone, which was further validated by significant anti-tumor activity in vivo when compared to WU-NK-101 alone.
WU-NK-101 in combination with mAbs demonstrated robust anti-tumor activity, showing enhanced trafficking, tumor infiltration, and persistence.
These data suggest that WU-NK-101 may overcome the current limitations of adoptive cellular therapies and support its clinical development in the solid tumor setting.
The details of Wugen’s presentation at ESMO (Free ESMO Whitepaper) are as follows:

Title: WU-NK-101: An Enhanced NK Cell Therapy Optimized for Function in the Tumor Microenvironment (TME)

Abstract Number: 11P

Date and Time: Sunday, September 11, 2022, from 12:00 – 13:00 CEST (6:00 – 7:00 a.m. EDT)

Location: Paris Expo Porte De Versailles, Poster Area, Hall 4

Additional meeting information can be found at View Source

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On September 10, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that updates from its solid tumor development program for cornerstone PD-1 antibody tislelizumab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris (Press release, BeiGene, SEP 10, 2022, View Source [SID1234619361]).

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Results from the Phase 3 RATIONALE 301 trial of tislelizumab versus sorafenib as first-line treatment in patients with unresectable hepatocellular carcinoma were accepted as a late-breaking abstract (LBA36) and presented at an oral session on Saturday, September 10. In the final analysis of 674 patients enrolled from Asia, Europe, and U.S., RATIONALE 301 met its primary endpoint of overall survival (OS) non-inferiority, with a median OS of 15.9 months for tislelizumab compared with an OS of 14.1 months for sorafenib (HR: 0.85 [95.003% CI: 0.712, 1.019]); superiority was subsequently tested, which was not met. OS data were consistent across all pre-specified subgroups, including regions.

In the RATIONALE 301 trial, tislelizumab was associated with a higher objective response rate (ORR) (14.3% vs. 5.4%) and more durable responses (median duration of response (DoR) 36.1 months vs. 11.0 months) compared with sorafenib. Median progression-free survival (PFS) for tislelizumab versus sorafenib was 2.1 months vs. 3.4 months respectively; HR: 1.11 [95% CI: 0.92, 1.33].

The safety profiles for tislelizumab and sorafenib treatments were consistent with previous studies, and tislelizumab demonstrated a comparatively favorable profile versus sorafenib with lower incidence rates of grade >3 adverse events (AEs) and AEs leading to discontinuation (48.2% vs 65.4% and 10.9% vs 18.5% respectively). AEs leading to death were low across both tislelizumab (4.4%) and sorafenib (5.2%) arm.

"The RATIONALE 301 study results confirm a durable overall survival benefit of single agent tislelizumab and we are pleased that the safety profile for tislelizumab is consistent with previous studies. While targeted therapies can be an important treatment modality for advanced hepatocellular cancer, the safety and tolerability profile remain an important consideration," said Mark Lanasa, M.D., Ph.D, Chief Medical Officer, Solid Tumors, at BeiGene. "We’re pleased to share the data at ESMO (Free ESMO Whitepaper) today and to engage with leading oncology researchers about our expansive clinical development program for tislelizumab in solid tumors."

In addition to the late-breaking Phase 3 RATIONALE 301 results, BeiGene shared posters demonstrating a consistent response for tislelizumab across pre-specified subgroups in a Phase 3 trial and indications of anti-tumor activity and tolerable safety profile in a Phase 1 trial with tislelizumab in combination with chemotherapy and investigational anti-TIGIT antibody ociperlimab:

Abstract 1031P – RATIONALE 303 (NCT03358875): Tislelizumab demonstrated favorable OS, PFS, DoR, and ORR compared with docetaxel, regardless of subgroup, in a prespecified analysis of Asian versus non-Asian patients in the global RATIONALE 303 study of tislelizumab versus docetaxel as second- or third-line therapy in previously treated patients with locally advanced non-small cell lung cancer (NSCLC) Lower rates of treatment-emergent adverse events were reported for tislelizumab versus docetaxel (41.1% vs 75.2% of Asian patients and 45.9% vs 72.9% of non-Asian patients, respectively).
Abstract 1017P –AdvanTIG-105 (NCT04047862): Ociperlimab and tislelizumab plus chemotherapy demonstrated antitumor activity in cohorts 1 and 2 of this Phase 1b dose-expansion study and the recommended Phase 2 dose showed a manageable safety profile in patients with metastatic squamous and non-squamous NSCLC.
BeiGene also shared posters describing the trial design for ongoing tislelizumab combination clinical trials:

Abstract 1194TiP – AdvanTIG-205 (NCT05014815): Phase 2 trial of ociperlimab + tislelizumab + chemotherapy in first line treatment of patients with locally advanced, unresectable, or metastatic NSCLC.
Abstract 1187TiP – BGB-A317-Sitra-301 (NCT04921358): Phase 3 study of tislelizumab with sitravatinib versus chemotherapy in patients with locally advanced/metastatic NSCLC previously treated with chemo and an anti-programmed cell death protein 1/ligand 1 antibody.
About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first investigational medicine from BeiGene’s immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination.

The global tislelizumab clinical development program includes more than 11,000 subjects enrolled to-date in 30 countries and regions. More information on the tislelizumab development program, including clinical trials and regulatory submissions, can be found on the Tislelizumab Fact Sheet in our corporate press kit.

About RATIONALE 301

RATIONALE 301 (NCT03412773) is a global, Phase 3, randomized, open-label study of tislelizumab compared with sorafenib as a first-line treatment in adult patients with unresectable HCC. The primary endpoint of the study is non-inferiority of OS between the two treatment groups. The key secondary endpoint is ORR, as assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1. Other secondary endpoints include other efficacy assessments such as PFS, DoR, and Time to Progression per BIRC, as well as measures of health-related quality of life, and safety and tolerability.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in more than 50 markets including the U.S., China, the European Union, Great Britain, Canada, Australia, and South Korea; and the non-FC-gamma receptor binding anti-PD-1 antibody, tislelizumab, as well as the PARP inhibitor, pamiparib, in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On September 10, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported data from a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Cell Lung Cancer (NSCLC) (Press release, Spectrum Pharmaceuticals, SEP 10, 2022, View Source [SID1234619359]). The data show that poziotinib is highly active in G778 mutations in both treatment naïve and previously treated patients with NSCLC.

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The poster titled "High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Cell Lung Cancer (NSCLC)" is being presented by Xiuning Le, M.D., Ph.D., Assistant Professor, The University of Texas MD Anderson Cancer Center on September 12, 2022. A poster with the data is available to registered participants at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2022 taking place in Paris from September 9-13, 2022.

"The G778 mutation is one of the frequent HER2 exon 20 insertion mutations and patients with these tumors have a poor prognosis," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "These findings demonstrate the high activity of poziotinib in both treatment naïve and heavily pre-treated patients."

Results for Poziotinib in this Patient Group

The findings are based on an assessment of the activity of poziotinib in patients with the G778_P780dup HER2 exon 20 insertion mutation in a population of previously treated (Cohort 2) and treatment-naïve (Cohort 4) patients with NSCLC from the ZENITH20 clinical trial. Patients (n=90) in Cohort 2 (C2) received 16 mg of poziotinib once a day (QD) and patients (n=80) in Cohort 4 (C4) received 16 mg QD or 8 mg twice a day (BID). The primary endpoint was objective response rate (ORR). Fourteen patients had the HER2 G778 insertion (C2, n=7; C4, n=7) mutation.

12 of 14 patients were evaluable and all had partial response, resulting in an ORR of 85.7% (95% CI, 57.2, 98.2) and a median DOR of 5.5 months (range 2.9-14.1). The ORR was 100% in the previously treated C2 patients, and 71.4% in the treatment naïve C4 patients. Median DOR was 5.3 months for the C2 patients and 8.9 months for those in C4. The frequency of adverse events (AEs) was consistent with prior reports and overall AEs were similar to the TKI class.

The poster will be available for viewing by registered participants during the conference via the ESMO (Free ESMO Whitepaper) website beginning on September 10, 2022. It will also be available on the Investor Relations section of the company’s website at View Source

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy specifically for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. The company holds an exclusive license from Hanmi Pharmaceutical to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.