On June 4, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported data from the gastrointestinal (GI) mid-gut neuroendocrine tumors (NETs) cohort of its Phase 2 clinical trial of PEN-221, presented at the 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Tarveda Therapeutics, JUN 4, 2021, businesswire.com/news/home/20210604005111/en/Tarveda-Therapeutics-Presents-Promising-Phase-2-Data-of-PEN-221-in-Gastrointestinal-Mid-gut-Neuroendocrine-Tumors [SID1234583590]).

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"The results presented at ASCO (Free ASCO Whitepaper) from the gastrointestinal mid-gut neuroendocrine cohort of the PEN-221 trial show that PEN-221 was well tolerated and demonstrated efficacy exceeding its clinical efficacy goals with a clinical benefit rate of 88.5% and median progression-free survival of 9 months," said Jeffrey Bloss, M.D., Chief Medical Officer of Tarveda. "We are encouraged by the safety and efficacy shown by PEN-221 in GI mid-gut NETs and are developing a randomized trial to further evaluate PEN-221 in this patient population."

"Gastrointestinal neuroendocrine tumors are a disease with a significant unmet need. While targeting SSTR2 receptors has been an effective strategy in treating GI NETs, there remains a need for additional therapies which delay disease progression and prolong patients’ lives," said Daniel M Halperin, M.D., Assistant Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "PEN-221 selectively binds with high affinity to SSTR2 expressed on neuroendocrine tumors, where it releases its DM1 payload directly into the tumor cells, causing cell cycle arrest and apoptosis. This approach demonstrated encouraging efficacy results in the GI mid-gut NET cohort of the Phase 2 trial and was well tolerated by patients."

The results presented had a data cutoff of July 31, 2020 and five patients remained on study at the time of the cutoff. Of the 32 patients included in these results, the first nine were treated at the Phase 1 determined maximum tolerated dose of 18 mg. After review of the safety, tolerability, and pharmacokinetic data, the regimen was amended to 8.8 mg/m2 for all subsequent patients to achieve more uniform exposures across all patients and reduce toxicity in patients with lower body-surface-area (BSA).

Trial Design

PEN-221 was administered as a one-hour intravenous infusion once every three weeks to patients with advanced SSTR2+ GI mid-gut NETs with documented radiographic progression within the six months prior to enrollment. Preliminary efficacy was assessed using RECIST 1.1. A clinically meaningful efficacy result was defined as a clinical benefit rate (CBR) > 75% and a median progression-free survival (mPFS) > 8 months.

Safety Data

A safety analysis of 32 patients demonstrated that PEN-221 was well tolerated when dosed at 8.8 mg/m2. The most frequent treatment related adverse events of any Grade were fatigue (39%), nausea (38%), diarrhea (35%), decreased appetite (30%), infusion reaction (24%), aspartate transaminase (AST)/alanine transaminase (ALT)/alkaline phosphatase (Alk Phos) increase (24%), and peripheral neuropathy (21%). Only 14 (10%) of these events were Grade 3 or greater. Grade 3 treatment related adverse events, which were reported in two or more patients, included fatigue (7.6%), ALT/AST/Alk Phos increase (7.6%), and peripheral neuropathy (3%).

Efficacy Data

PEN-221 demonstrated efficacy at 8.8 mg/m2 with a CBR of 88.5% and mPFS of 9 months. Of the 26 patients who were evaluable for response, 23 (88.5%) had stable disease (SD) reported as their best response and target lesion shrinkage was observed in 10 (38%) patients.

A randomized trial of PEN-221 in GI mid-gut NET patients is now in development.

The poster presentation is available on demand on the ASCO (Free ASCO Whitepaper) website beginning on June 4, 2021 at 9:00 AM ET. Details of the poster presentation are as follows:

Title: The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 results.
Abstract Number: 4110

About PEN-221

PEN-221 is a miniature drug conjugate consisting of a peptide ligand, that is highly selective in targeting SSTR2, joined through a cleavable linker to the potent cytotoxic payload DM1. SSTR2 is overexpressed on the cell surface of a range of solid tumors including neuroendocrine tumors and small cell lung cancers. In non-clinical experiments, PEN-221 binds with high affinity and selectivity to SSTR2. On binding, PEN-221 triggers SSTR2 internalization resulting in the accumulation of the DM1 payload in tumor cells followed by cell cycle arrest and apoptosis.

PEN-221 is being evaluated in Phase 2a expansion cohorts enrolling patients with mid-gut neuroendocrine tumors, pancreatic neuroendocrine tumors, and small cell lung cancer (ClinicalTrials.gov Identifier: NCT02936323).

On June 4, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Amgen to be a specialty pharmacy partner for LUMAKRAS (sotorasib), a new oral treatment for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy (Press release, Onco360, JUN 4, 2021, View Source [SID1234583589]).

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"Onco360 is honored to be selected as a specialty pharmacy provider for LUMAKRAS in partnership with Amgen," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of LUMAKRAS unlocks the first FDA-approved treatment option for patients with previously treated advanced or metastatic KRAS G12C-mutant NSCLC. As a provider of this key treatment, Onco360 is committed to supporting the highly specialized needs of NSCLC patients."

ABOUT METASTATIC NON-SMALL CELL LUNG CANCER

According to the National Cancer Institute’s (NCI’s) Surveillance, Epidemiology, and End Results (SEER) program, 235,760 patients will be diagnosed with lung cancer in 2021, with a corresponding 131,880 deaths. When considering all stages and histologic subtypes of the disease, the five-year overall survival (OS) of lung cancer is 21.7%. Patients with Stage IV metastatic disease have a five-year OS of only 6.3%. Unfortunately, 56% of lung cancer patients have metastatic disease upon initial diagnosis. Up to 85% of lung cancer cases are classified as NSCLC.1 Approximately 13% of NSCLC patients have KRAS G12C mutations.2

LUMAKRAS is manufactured by Amgen, a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. The FDA’s approval of LUMAKRAS comes as a result of a 124 patient subset of the Phase I/II CodeBreak 100 clinical trial (NCT03600883) which demonstrated that previously treated patients with metastatic KRAS G12C-mutant NSCLC experienced a 36% objective response rate (ORR) after LUMAKRAS ad

On June 4, 2021 Lvgen Biopharma, a biotech company focused on developing innovative immuno-oncology therapeutics, reported that it will present a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), to be held in a virtual format from June 4 to 8, 2021 (Press release, Lyvgen Biopharma, JUN 4, 2021, View Source [SID1234583587]).

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The Trials in Progress poster presentation summarizes the safety profile, antitumor activity observed in a phase I clinical trial (NCT04130542) in collaboration with Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside of the U.S. and Canada. The trial is evaluating LVGN6051, a second generation 4-1BB (CD137) agonist antibody based on Lyvgen proprietary xLinkAb platform, as monotherapy or in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in adult patients with advanced malignancies. No MTD was reached at 7 mg/kg monotherapy and 4 mg/kg q3w monotherapy was determined as RP2D. Preliminary antitumor activity in late stage cancer patients was observed. Combination with pembrolizumab induced rapid antitumor responses in advanced cancer patients with immune-cold tumor or relapsed from prior immunotherapies.

Presentation Details:

Abstract title: Early safety and efficacy from a phase I open-label clinical trial of CD137 (4-1BB) agonistic antibody LVGN6051 as monotherapy and in combination with pembrolizumab.
Abstract number: 2521
Poster Session: Developmental Therapeutics—Immunotherapy
The 2021 ASCO (Free ASCO Whitepaper) Annual Meeting will take place virtually on June 4 – 8, 2021 via the ASCO (Free ASCO Whitepaper) website, View Source

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LVGN6051

LVGN6051 is xLinkAb anti-4-1BB (CD137) agonist mAb that has been designed to activate 4-1BB optimally in tumor microenvironment by targeting both 4-1BB and FcγRIIB. LVGN6051 strikes a balance between antitumor efficacy and safety by agonizing 4-1BB only in the presence of FcγRIIB, which is expressed on immune cells enriched in the tumor microenvironment, including B cells, dendritic cells and granulocytes.

On June 14, 2021 POINT Biopharma Inc. (POINT), a global radiopharmaceutical company dedicated to successfully delivering precision radioligand therapy to cancer patients, reported that it has successfully dosed multiple patients in its Phase 3 SPLASH study evaluating the efficacy of PNT2002, the Company’s investigational 177Lu-PSMA targeted radioligand therapy for patients with PSMA expressing metastatic castration resistant prostate cancer (mCRPC) who are not eligible for chemotherapy (Press release, Point Biopharma, JUN 4, 2021, View Source [SID1234583586]).

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The Phase 3 SPLASH study is a multi-center, randomized, open label assessment of PNT2002 in patients with mCRPC who have progressed on ARAT therapy and refuse or not eligible for chemotherapy. The study will commence with a single-arm dosimetry lead-in and expects to enroll a total of approximately 450 patients across North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK).

"We are pleased to announce dosing of patients in our Phase 3 SPLASH study, which represents a significant milestone for POINT. I am very proud of the work our clinical and CMC teams have done to bring us to this stage and believe that this study holds the potential to demonstrate an improvement against the current standard of care for patients with little to no current therapeutic options," said Joe McCann, Chief Executive Officer of POINT Biopharma. "It is exciting to be working on PSMA targeted radiopharmaceuticals, a technology which will likely continue to gain interest as results from studies like the VISION trial are published. We appreciate the collaboration and engagement from our trial investigators as well as the guidance from global key opinion leaders in the field."

The first patients in the trial were dosed last month by Dr. Luke Nordquist, Urologic Medical Oncologist, Urology Cancer Center & GU Research Network, Omaha, Nebraska, and Dr. Ebrahim Delpassand, Nuclear Medicine Physician, Excel Diagnostics and Nuclear Oncology Center, Houston, Texas. "There is a significant unmet need for therapeutic alternatives with a novel mechanism of action for patients with PSMA expressing mCRPC, particularly in advance of chemotherapy. The current standard of care is not sufficient for patients with this aggressive form of cancer," said Dr. Nordquist. "As a nuclear medicine physician with special interest in nuclear Oncology, I have seen an increasing demand and appreciation for this therapeutic modality and believe it holds much promise as the future of precision medicine," added Dr. Delpassand.

Additional information on the Phase 3 SPLASH study can be found at View Source

POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol "PNT". A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.

On June 4, 2021 Physicians from Dallas-based Texas Oncology and researchers from Seattle-based Navigating Cancer will present two posters highlighting the benefits of electronic patient management at the virtual 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which takes place June 4-8, 2021 (Press release, Navigating Cancer, JUN 4, 2021, View Source [SID1234583585]). The two poster presentations examine the impact that Navigating Cancer’s digital monitoring program, Health Tracker, has on symptom management for cancer patients at a large, multi-site community oncology practice.

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The first poster session titled, "Implementation of Electronic Patient-Reported Outcomes (ePROs) for Symptom Monitoring in a Large Multi-Site Community Oncology Practice," is part one of the Texas Two-Step study, a two-part (hybrid) implementation-effectiveness evaluation of ePROs. In part one of the Texas Two-Step study, researchers found that utilization of the ePRO tool can help provide just-in-time symptom management and, despite the challenges of the global COVID-19 pandemic on cancer practices, implementation of ePROs for digital symptom monitoring across a large multi-site statewide cancer practice is feasible, and compliance is high. Step two of the Texas Two-Step study will evaluate the impact ePROs have on healthcare resource utilization, time on therapy, and symptom control.

"The data shows that digital healthcare systems like Health Tracker can help clinicians manage their patients’ symptoms quickly and efficiently, potentially leading to improved clinical outcomes, fewer visits to emergency departments, higher patient satisfaction, and compliance with therapy," said lead author Debra Patt, M.D., Ph.D., MBA, medical oncologist and executive vice president, public policy, and strategic initiatives at Texas Oncology. "For cancer patients especially, response time is critical, and this technology allows care teams to monitor a patient’s symptoms in real-time and swiftly respond to patients who are in need and require symptom control. It also gives us better insight on compliance with oral therapies."

The second poster session titled, "Improvement in Incident Resolution Time with the Implementation of an Electronic Patient Management Solution at a Community Oncology Practice," evaluates the impact of the digital monitoring program on time to symptom resolution – prolonged times to system resolution can lead to unnecessary emergency department visits. The researchers found that the program, with Plan Do Study Act (PDSA) cycles of quality improvement, can markedly improve incident resolution times, especially for symptom-related calls.

"Staying connected with cancer patients and monitoring their symptoms outside of the clinic can be challenging for busy clinicians," said Bill Bunker, CEO of Navigating Cancer. "This research demonstrates that when technology is effectively integrated into existing practice workflows, it can fill this care gap and drive improved outcomes and better experiences for patients."

Texas Oncology focuses on delivering quality cancer care and mitigating healthcare disparities for Texans fighting cancer through its locations in communities of all sizes throughout the state, including smaller cities and towns. In addition, telemedicine connects patients with care teams both locally and with access to specialized physician expertise in other cities. Online support groups, including nutrition support groups, serve patients no matter where they live so they can receive the critical support they need.

The full abstracts and both posters are available at NavigatingCancer.com/publications. Additional insights into the Texas Two-Step study are available in the JCO Clinical Cancer Informatics.

Abstract Summaries:

Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multi-Site Community Oncology Practice, Abstract 12103

Lead author: Debra Patt M.D., Ph.D., MBA, medical oncologist and executive vice president, public policy, and strategic initiatives at Texas Oncology

Patients initiating a new systemic therapy at one of 210 Texas Oncology practice sites were invited to use the Navigating Cancer ePRO platform from July-December 2020. Participating patients received a weekly prompt by SMS text message or email (patient choice) to self-report common symptoms and well-being via computer or smartphone. Severe self-reported symptoms triggered a real-time notification alert to a triage nurse to address the symptom.

Highlights:

More than 4,000 cancer patients initiating systemic therapy enrolled in the program throughout the study period with 25% of patients living more than 20 miles from their clinic.
Of the patients who were enrolled in the platform, 73% completed at least one ePRO assessment, and among these individuals, 65% of all available weekly ePRO assessments were completed.
SMS (89%) was strongly preferred over email (6%) or clinic collect (5%). SMS was also associated with the highest participation rate (77%) vs. email (54%) or clinic collect (45%).
Improvement in Incident Resolution Time with the Implementation of an Electronic Patient Management Solution at a Community Oncology Practice, Abstract 1578

Lead author: Lalan Wilfong, M.D., medical oncologist and executive vice president for value-based care and quality programs at Texas Oncology

Incident volumes and resolution times were monitored at all Texas Oncology locations along with the implementation of PDSA cycles, which had a goal of less than 90-minute resolution of symptom-related incidents. Utilizing Navigating Cancer’s electronic dashboard allowed Texas Oncology to continue this initiative during the pandemic as some staff could work remotely. Nurses could document if a potential emergency department visit was avoided, and these data points allowed the practice to establish comprehensive and strategic actions plans for quality improvement.

Highlights:

Resolution time for all incidents started at 3.2 hours pre-implementation and improved to 2.2 hours in December 2020.
Sixty-two percent of symptom-related incidents were resolved in less than one hour.
Eight percent of symptom-related incidents resulted in definite or probable emergency department avoidances by nursing assessment.
Shortness of breath, vomiting, chills, and weakness were the top symptom types addressed for emergency department avoidances.