On April 26, 2023 Seagen Inc. (Nasdaq: SGEN) reported the presentation of 17 abstracts at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023, in Chicago (Press release, Seagen, APR 26, 2023, View Source [SID1234630544]). Data will be presented across Seagen’s portfolio of approved medicines and pipeline agents in a range of cancer types and in earlier lines of therapy.

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"Seagen has worked towards revolutionizing cancer care for 25 years by linking scientific innovation to meaningful impacts in patients’ lives," said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen. "Our data presented at ASCO (Free ASCO Whitepaper) demonstrate continued progress in our efforts to discover and develop transformative medicines."

Highlights include new data from a robust clinical development program in bladder cancer with trials across multiple lines of treatment and into earlier stages of disease for muscle-invasive and non-muscle invasive forms of bladder cancer. Long-term follow-up data from a clinical trial of PADCEV (enfortumab vedotin-ejfv) (EV-103 dose-escalation and Cohort A) will be featured in an oral presentation on Monday, June 5. The EV-103 dose-escalation/Cohort A study is evaluating PADCEV, developed in partnership with Astellas, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment in patients with locally advanced or metastatic urothelial carcinoma who are ineligible to receive cisplatin-based chemotherapy. Merck is known as MSD outside the United States and Canada.

Updated Phase 1 data will be presented for SGN-B6A, a wholly-owned, first-in-class vedotin ADC directed to integrin beta-6, a novel target that is highly expressed in multiple solid tumors.

Additionally, initial data will be presented from studies evaluating Seagen’s approved medicines in potential new cancer types. Data from a Phase 2 basket study of TUKYSA (tucatinib) and trastuzumab in previously treated HER2-positive metastatic biliary tract cancer will be featured in an oral presentation on Friday, June 2.

Key data presentations for Seagen include:

Presentations of Company-Sponsored Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Enfortumab Vedotin

Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up

4505

Oral
Monday, June 5
11:30 a.m. – 2:30 p.m. CT

S. Gupta

Enfortumab vedotin in the previously treated advanced head and neck cancer (HNC) cohort of EV-202

6017

Poster Discussion

Monday, June 5
1:15 – 4:15 p.m. CT

P. Swiecicki

A first-in-human trial of intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC), in patients with non-muscle invasive bladder cancer (NMIBC): Interim results of a phase 1 study (EV-104)

4596

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

A. Kamat

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H

4595

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

T. Flaig

Enfortumab vedotin (EV) with or without pembrolizumab (P) in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on Cohort K data

4568

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

T. Friedlander

EV-203: Phase 2 trial of enfortumab vedotin in patients with previously treated advanced urothelial carcinoma in China

e16574

Online Abstract

Q. Li

Enfortumab Vedotin Trials in Progress

KEYNOTE-905/EV-303: A phase 3 study to evaluate the efficacy and safety of perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC) (ENCORE)

TPS4601

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

A. Necchi

Tucatinib

Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer (SGNTUC-019): A phase 2 basket study

4007

Oral
Friday, June 2
2:45 – 5:45 p.m. CT

Y. Nakamura

Real-world patient characteristics and treatment patterns associated with tucatinib therapy in patients with HER2+ metastatic breast cancer

1051

Poster
Sunday, June 4
8:00 – 11:00 a.m. CT

C. Anders

HER2 testing in the MOUNTAINEER trial: Analysis of treatment response based on central HER2 assessment using IHC/ISH and NGS

3528

Poster
Monday, June 5
8:00 – 11:00 a.m. CT

J. Strickler

Tucatinib Trials in Progress

HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (trial in progress)

TPS1115

Poster
Sunday, June 4
8:00 – 11:00 a.m. CT

E. Hamilton

MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and modified FOLFOX6 as first line treatment in HER2+ metastatic colorectal cancer (trial in progress)

TPS3631

Poster
Monday, June 5
8:00 – 11:00 a.m. CT

T. Bekaii-Saab

Early-Stage/Pipeline

SGN-B6A, an integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors: Updated results from a phase 1 study (SGNB6A-001)

3024

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

A. Hollebecque

Early-Stage/Pipeline Trials in Progress

Phase 1 study of SGN-BB228, an investigational CD228 x 4-1BB costimulatory antibody anticalin bispecific, in patients with advanced melanoma and other solid tumors (SGNBB228-001: trial in progress)

TPS9597

Poster
Saturday, June 3
1:15 – 4:15 p.m. CT

J. Henry

Presentations of Investigator-Sponsored Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Enfortumab Vedotin
Real-world use, dose intensity, and adherence to an antibody-drug conjugate (ADC) in metastatic urothelial cancer (mUC)
e16567

Online Abstract

R. Mamtani

Tucatinib

UCLA B-13: A phase 1b trial evaluating the safety of ribociclib, tucatinib, and trastuzumab in patients with metastatic, HER2+ breast cancer and a multicenter, randomized, open-label, phase 2 study of preoperative treatment with ribociclib, trastuzumab, tucatinib, with or without fulvestrant versus docetaxel, carboplatin, trastuzumab, and pertuzumab in HR+/HR-, HER2+ breast cancer

TPS1116

Poster
Sunday, June 4
8:00 – 11:00 a.m. CT

N. McAndrew

Disitamab Vedotin

Disitamab vedotin, a novel humanized anti-HER2 antibody-drug conjugate (ADC) combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma: an open-label phase 1b/2 study

4566

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

X. Sheng

On April 26, 2023 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported that it will present a poster on FLX475, its lead oncology drug candidate, at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place June 2-6, 2023 at the McCormick Place Convention Center in Chicago, IL (Press release, RAPT Therapeutics, APR 26, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-flx475-poster-presentation-2023 [SID1234630542]).

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Presentation details:

Title: Clinical and Biological Activity of FLX475, an Oral CCR4 Antagonist, in Advanced Cancer
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday, June 3, 2023; 8:00 a.m. – 11:00 a.m. ET
Abstract Number: 2625
The abstract will be released on Thursday, May 25, 2023 at 5:00 p.m. ET on meetings.asco.org.

On April 26, 2023 PharmaMar Group (MSE: PHM) reported total revenues of €34.0 million in 1Q2023, compared with €53.2 million in 1Q2022. Recurring revenues, the sum of net sales plus royalties from sales made by our partners, totaled €27.4 million compared with €45.9 million in the first quarter of 2022 (Press release, PharmaMar, APR 26, 2023, View Source [SID1234630541]). This difference is mainly due to the entry onto the European market of a generic trabectedin (Yondelis) product in the last quarter of 2022. Yondelis reported net sales of €8.1 million in the first quarter of this year, compared with €17.5 million in the same period of the previous year. The entry of the generic drug has put significant pressure on the price of Yondelis, although the change in sales measured in grams was 9% year-on-year.

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Zepzelca revenues in Europe from the early access program, mainly in France, were €5.6 million, in line with the last quarters of last year, although in the first quarter of 2022 they were €8.7 million. While the number of units sold was similar to the same period last year; there is a difference between periods due to the calculation of the adjustments resulting from the regulations governing the prices of drugs marketed through the L’autorisation d’ Access Compasionel system in France, under which Zepzelca is distributed in that territory, entailing the application of significant discounts for these drugs.

Continuing with recurring revenues, sales of raw materials to our partners, both of Yondelis and Zepzelca, amounted to €1.5 million in the first quarter of the year, compared with €7.4 million in the first quarter of 2022. This difference is temporary as our partners stocked up in previous quarters and there is a lag in purchase orders, so that this item is expected to rebound in the coming months.

Royalty income totaled €11.1 million, in line with the €11.0 million recorded during the first quarter of the same period last year. These revenues include royalties received from our partner Jazz Pharmaceuticals for Zepzelca sales in the US, which amounted to €10.2 million to March 31st (March 2022: €10.2 million). The royalties recorded for the first quarter are an estimate, as was the figure recorded in the first quarter of last year, since information on sales made by Jazz is not available at the date of publication of this report. Any discrepancies between our estimates and the final figure will be corrected in the following quarter. The real growth in royalties between the two periods was 7%, which is not reflected due to an excess in the forecast made in the royalties for the first quarter of 2022.

To the Royalties received from Jazz Pharmaceuticals must be added to the royalties on Yondelis sales received from our partners in the United States and Japan, amounting to €0.9 million in the first quarter of 2023 (€0.8 million in the same period of 2022).

Finally, non-recurring revenues, mainly consisting of those from licensing agreements, amounted to €6.5 million at March 31st, 2023, compared with €7.2 million at March 31st, 2022. In the first quarter of 2023, as well as in 2022, the revenues recorded for this item came entirely from licensing agreements related to Zepzelca.

During the first quarter of the year, R&D expenditure increased by 11% to €21.1 million, mainly as a result of the various Phase III trials, which the Company is conducting as well as the development of new molecules at earlier stages of the pipeline.

The Group recorded a net profit in this first quarter 2023 of €1.4 million, compared to €21.9m in first quarter 2022, mainly due to the drop in sales and the increase in R&D investment.

The PharmaMar Group ended the first quarter of 2023 with cash of €231.1 million and total debt of €39.8 million, which represents net cash of €191.4 million, in line with the cash position at the end of 2022.

PharmaMar’s earnings conference call for analysts and investors

PharmaMar will hold a conference call with analysts and investors on Thursday, April 27th, 2023, at 12:30 (CET).

To access this teleconference, please follow this link to register and receive conference call details:

View Source

A recording of the teleconference can be accessed on PharmaMar’s website by visiting the Events Calendar section at www.pharmamar.com.

On April 26, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the acceptance of an abstract for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place from June 2 – 6, 2023 in Chicago, Illinois and online (Press release, Oncolytics Biotech, APR 26, 2023, View Source;metastatic-breast-cancer-at-the-asco-annual-meeting [SID1234630540]).

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"Being selected for an oral presentation at ASCO (Free ASCO Whitepaper) is an immense honor that speaks to the importance of BRACELET-1’s results to key opinion leaders and other critical stakeholders in breast cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "ASCO is widely recognized as one of the world’s premier oncology conferences, and we’re thrilled that our collaborators at PrECOG will have such a prestigious venue to present the randomized phase 2 BRACELET-1 trial."

Details on the abstract and corresponding presentation are shown below.

Title: BRACELET-1 (PrE0113): Inducing an Inflammatory Phenotype in Metastatic HR+/HER2- Breast Cancer with the Oncolytic Reovirus Pelareorep in Combination with Paclitaxel and Avelumab

Presentation Type: Oral

Abstract Number: 1012

Session Type: Clinical Science Symposium

Session Title: The Dr. Bernard Fisher Memorial Annual Clinical Science Symposium Supported by the Breast Cancer Research Foundation: Harnessing the Breast Cancer Immune Response

Session Date and Time: June 3, 2023 | 1:15 p.m. – 2:45 p.m. CT

The abstract will be published on the ASCO (Free ASCO Whitepaper) Annual Meeting website at 5:00 p.m. ET on May 25, 2023.

About BRACELET-1

Additional information on the BRACELET-1 study can be found at View Source and the identifier (NCT number) NCT04215146.

On April 26, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the acceptance of multiple abstracts for poster presentations at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place in Chicago from June 2-6, 2023 (Press release, Mersana Therapeutics, APR 26, 2023, View Source [SID1234630536]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation details are as follows:

XMT-1660: A phase 1b trial of a B7-H4 targeted antibody drug conjugate (ADC) in breast, endometrial, and ovarian cancers
Abstract Number: TPS3154
Presenter: Erika Hamilton, MD, Director, Breast Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology
Session Track & Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date & Time: June 3 from 8:00-11:00 a.m. CT

Correlating expression of NaPi2b and FRa in high grade serous ovarian cancer (HGSOC)
Abstract Number: 5545
Presenter: Debra Richardson, MD, Associate Professor, Obstetrics & Gynecology and Section Chief of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Session Track & Title: Poster Session – Gynecologic Cancer
Session Date & Time: June 5 from 1:15-4:15 p.m. CT

UP-NEXT (GOG-3049/ENGOT-Ov71-NSGO-CTU): A study of upifitamab rilsodotin (UpRi), a NaPi2b-directed antibody drug conjugate (ADC), in platinum-sensitive recurrent ovarian cancer
Abstract Number: TPS5614
Presenter: Debra Richardson, MD, Associate Professor, Obstetrics & Gynecology and Section Chief of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Session Track & Title: Poster Session – Gynecologic Cancer
Session Date & Time: June 5 from 1:15-4:15 p.m. CT

UPGRADE-A: Phase 1 expansion trial of the NaPi2b-directed antibody drug conjugate (ADC) upifitamab rilsodotin (UpRi) in combination with carboplatin in patients with high-grade serous ovarian cancer (HGSOC)
Abstract Number: TPS5613
Presenter: John Hays, MD, PhD, Assistant Professor, Department of Internal Medicine, Division of Medical Oncology, The Ohio State University
Session Track & Title: Poster Session – Gynecologic Cancer
Session Date & Time: June 5 from 1:15-4:15 p.m. CT