On May 26, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that pooled analyses from its Phase 1 and pivotal trials with afami-cel for synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Adaptimmune, MAY 26, 2022, View Source [SID1234615189]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"People with sarcoma struggle with limited treatment options that are often ineffective and toxic," said Brandi Felser, Chief Executive Officer of the Sarcoma Foundation of America. "New and innovative treatments are long overdue for people with sarcoma."

"Our cell therapy, afami-cel, has produced impressive clinical responses in heavily pre-treated patients with late-stage, rare sarcomas – a patient population with a high unmet medical need," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "Obtaining commercial approval for afami-cel for the treatment of synovial sarcoma is a top priority, and the pivotal trial, SPEARHEAD-1, met its primary endpoint for efficacy last year. These data provide evidence of the benefits of afami-cel across patient sub-groups, and further inform SPEAR T-cell development strategies for the treatment of solid tumors."

Data support the potential of afami-cel as a treatment option for people with rare sarcomas

Afami-cel is a cell therapy that uses a patient’s own T-cells to express an engineered T-cell receptor (TCR) designed to kill cancer cells in solid tumors expressing a protein called MAGE-A4
Pooled data were analyzed[1] from 69 patients with synovial sarcoma or MRCLS who received afami-cel in the Phase 1 trial or Cohort 1 of the SPEARHEAD-1 trial
The overall response rate was 36% in heavily pre-treated patients across both types of sarcomas (41% in synovial sarcoma and 10% for MRCLS), with a median duration of response of 52 weeks
Responses occurred across subgroups (i.e., age, gender, number of prior lines of therapy, tumor burden, and MAGE-A4 expression level)
Lower baseline tumor burden, fewer prior lines of prior therapy, and higher MAGE-A4 expression were associated with greater response rates
Among patients with clinical responses, median progression-free survival (PFS) was 58 weeks compared to 12 weeks in non-responders
Patients who received 2 or fewer prior lines of therapy had a response rate of 49% compared to 24% for patients who received 3 or more
As reported last year, the pivotal trial SPEARHEAD-1 met its primary endpoint for efficacy and the benefit:risk profile of afami-cel has been favorable with mainly low-grade cytokine release syndrome and tolerable/reversible hematologic toxicities
Adaptimmune is on-track for BLA submission to FDA in Q4 2022 and planned commercial launch in 2023

On May 26, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval for an additional indication of the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for the adjuvant treatment of PD-L1-positive non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare (Press release, Chugai, MAY 26, 2022, View Source [SID1234615074]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

VENTANA OptiView PD-L1 (SP263), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. An expanded use of this test kit as a companion diagnostic for Tecentriq was approved on May 23, 2022 to allow physicians to identify patients with PD-L1-positive NSCLC who could benefit from Tecentriq.

"I am very pleased that we can offer Tecentriq as the first cancer immunotherapy for adjuvant treatment of NSCLC. This makes cancer immunotherapy available for certain patients with early-stage NSCLC," said Chugai’s President and CEO, Dr. Osamu Okuda. "In early-stage cancer, it is critical to prevent recurrence and increase the chance of cure, the ultimate goal of treatment. Tecentriq is the first cancer immunotherapy to demonstrate a reduction in the risk of recurrence or death in early-stage lung cancer, for which there has been no significant progress in treatment over the past decade. We will continue our efforts to provide information on the proper use of Tecentriq in order to contribute to postoperative adjuvant treatment of non-small cell lung cancer."

This approval is based on the results from phase III IMpower010 study examining Tecentriq as an adjuvant treatment in NSCLC. The study showed that treatment with Tecentriq following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC, whose tumors express PD-L1≥1%, compared with best supportive care (BSC). The most frequent adverse reactions (5% or more) included hypothyroidism, pruritus, rash, increased AST, increased ALT, hyperthyroidism, pyrexia, and arthralgia.

Approval Information *Newly added description
Indications:
Adjuvant treatment of PD-L1-positive non-small cell lung cancer

Dosage and administrations:
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. The dosage period is up to 12 months. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.

Chugai Files for Additional Indication of Tecentriq for the Adjuvant Treatment of Non-small Cell Lung Cancer (July 7, 2021)
View Source

Pivotal Phase III data at ASCO (Free ASCO Whitepaper) show Roche’s Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning (Press release by Roche issued on May 20, 2021)
View Source

About IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

About non-small cell lung cancer (NSCLC)
In Japan, 122,825 people (82,046 men and 40,777 women; 2018) reportedly become afflicted with lung cancer each year. 75,585 people in Japan (53,247 men and 22,338 women; 2020) reportedly die as a result of the disease. Lung cancer is the leading cause of cancer death.1) Lung cancer can be broadly divided into small cell lung cancer and NSCLC, according to the tissue type. NSCLC has the largest number of patients, accounting for about 85% of all lung cancer cases.2)

About approval status of Tecentriq in Japan
Tecentriq was launched in Japan in April 2018 for unresectable, advanced or recurrent non-small cell lung cancer (NSCLC), followed by an approval for the additional dosing for the treatment of untreated unresectable, advanced or recurrent NSCLC in December 2018. In 2019, the drug obtained regulatory approval for additional indications of extensive-stage small cell lung cancer in August, PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer in September, and for an additional dosing for the treatment of chemotherapy-naïve unresectable advanced or recurrent non-squamous NSCLC in November. In 2020, Tecentriq was approved for the treatment of unresectable hepatocellular carcinoma in September, followed by an approval for the additional dosing for the treatment of untreated PD-L1-positive, unresectable, advanced or recurrent NSCLC in December.

Trademarks used or mentioned in this release are protected by law.

Sources

Cancer Registry and Statistics. Cancer Information Service, National Cancer Center Japan from: View Source Accessed May 2022
American Cancer Society: What Is Lung Cancer? View Source Accessed May 2022

On May 26, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported the presentation of the design and rationale of a Phase 1 trial-in-progress (KIN-4802, NCT05242822) evaluating the Company’s pan-FGFR inhibitor product candidate, KIN-3248 (Press release, Kinnate Biopharma, MAY 26, 2022, View Source [SID1234615091]). The details will be presented during a poster session on June 6, 2022, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place in Chicago, IL, June 3-7.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"A major limitation of approved and clinical-stage FGFR treatments is the emergence of secondary, on-target resistance mutations that reduce duration of response, highlighting the urgency to further research and develop more efficacious next-generation therapies for these patients," said the trial’s co-investigator and presenter Lipika Goyal, MD, a faculty member in Gastrointestinal Medical Oncology at Mass General Cancer Center. "We are pleased to share additional details of this two-part Phase 1 trial-in-progress evaluating KIN-3248 at this year’s ASCO (Free ASCO Whitepaper) conference."

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is a multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other selected adult solid tumors. This trial is currently enrolling across multiple sites in the United States.

"Unfortunately, acquired resistance to FGFR inhibitors frequently emerges during therapy for patients with FGFR-driven cancers, creating an urgent need to develop more effective and durable targeted therapies for these patients," said Richard Williams, MBBS, Ph.D., Chief Medical Officer of Kinnate. "We are pleased with the recent initiation of this first-in-human trial of KIN-3248, in collaboration with Mass General Cancer Center and other participating sites, and are grateful to the patients and physicians involved, without whom this research would not be possible."

In addition, in an abstract published in the ASCO (Free ASCO Whitepaper) meeting proceedings, the Company also shared updates from its preclinical in vitro and in vivo preclinical studies evaluating KIN-2787 in combination with binimetinib. In these studies, KIN-2787 demonstrated significant combination benefit in NRAS-mutant melanoma models. Taken together with its unique selectively, these data support the use of KIN-2787 in combination therapy in this patient segment. Melanoma tumor cell lines bearing NRAS Q61 alterations demonstrated synergistic benefit with KIN-2787 combined with binimetinib. Daily KIN-2787 plus binimetinib treatment in NRAS-altered melanoma xenograft models resulted in significant tumor growth inhibition benefit relative to either agent alone and was associated with added MAPK pathway biomarker suppression. A Phase 1/1b dose escalation and expansion clinical trial evaluating the safety and efficacy of KIN-2787 is ongoing (NCT04913285).

Abstracts accepted for the ASCO (Free ASCO Whitepaper) Annual Meeting include:

For additional information, visit the ASCO (Free ASCO Whitepaper) Annual Meeting webpage: View Source

Kinnate will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 3047.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in two upcoming investor conferences (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615107]). Veracyte will present at the William Blair 42nd Annual Growth Stock Conference on Wednesday, June 8, and will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Monday, June 13 .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Event: William Blair 42nd Annual Growth Stock Conference
Date: Wednesday, June 8, 2022
Time: 10:40 a.m. PT / 1:40 p.m. ET

Event: Goldman Sachs 43rd Annual Global Healthcare Conference
Date: Monday, June 13, 2022
Time: 2:40 p.m. PT / 5:40 p.m. ET

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.

On May 26, 2022 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that interim safety data from its ongoing Phase 1 RAD-18-002 clinical trial assessing the dose, safety, and tolerability of Radspherin, in patients with peritoneal carcinomatosis from colorectal carcinoma will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place in Chicago, IL (both in-person and virtually) from June 3 to 7, 2022 (Press release, Oncoinvent, MAY 26, 2022, View Source [SID1234615123]). The poster, titled "First experience with 224Radium-labelled microparticles (Radspherin) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study)" will be presented by Principle Investigator Stein Gunnar Larsen, MD during the "Gastrointestinal Cancer – Colorectal and Anal" session at 9:00 a.m. EDT on June 4, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited to share these compelling and important interim safety data at ASCO (Free ASCO Whitepaper), which continues to demonstrate that all dose levels of Radspherin are well tolerated with no dose limiting toxicities due to the Radspherin treatment observed to date," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "The data to be presented provides strong support as we progress Radspherin through clinical development. In particular, the observed biodistribution of Radspherin in this study is highly encouraging. We look forward to reporting longer-term safety, dosimetry, and first efficacy results of Radspherin later this year."

Details of the poster presentation are as follows:

Poster Presentation Title: First experience with 224Radium-labelled microparticles (radspherin) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study).
Session Title: Gastrointestinal Cancer – Colorectal and Anal
Date/Time: June 4, 2022 at 9:00 a.m. EDT
Presenting Author: Stein G Larsen
Abstract Number: 3599

This first-in-human Phase 1 study is designed to evaluate the safety and tolerability of Radspherin after dose escalation at increasing levels of 1-2-4-7 MBq and explore the highest tolerated dose and biodistribution. In this planned safety interim analysis, conducted 21 days following administration at two specialized cytoreductive surgery-hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) centers (Norwegian Radium Hospital and Uppsala University Hospital), a total of 23 patients were enrolled; 14 in the dose escalation cohort, 3 in the repeated cohort, and 6 in an expansion cohort. Radspherin was injected in the abdominal cavity through an in-dwelling catheter 2 days after completion of CRS-HIPEC. The maximal tolerated dose and biodistribution were evaluated by single photo-emission computed tomography and computed tomography (SPECT/CT) imaging.

Key results:

The biodistribution of Radspherin showed a relatively even peritoneal distribution, and no patients had compartments of the abdominal cavity without radioactivity, and the number of hot spots were low.
No serious adverse events were observed related to treatment with Radspherin.
The 7Mbq dose was selected as recommended dose as no dose limiting toxicity (DLT) was observed at this level.
Radspherin is also being evaluated at the 7Mbq dose in a Phase 1 open-label, dose-escalation clinical trial in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery.

About the RAD-18-002 Study

The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety, and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal carcinoma following complete cytoreductive surgery and HIPEC. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.