On May 29, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients with cancer, announces the presentation of data affirming the ability of its Target Selector platform to identify potentially actionable mutations in the cerebrospinal fluid of patients whose cancer has metastasized to the central nervous system (Press release, Biocept, MAY 29, 2020, View Source [SID1234558761]). The data were presented today by Kevin Kalinsky, MD, MS, associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons, an oncologist at New York-Presbyterian/Columbia University Irving Medical Center, and the study’s principal investigator, in a poster at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. The abstract is available here.

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The presence of tumor cells in cerebrospinal fluid may be an indicator of brain metastases, which occur when cancer has spread to the central nervous system. Biocept’s Target Selector assays can detect circulating tumor cells (CTCs) and circulating DNA (ctDNA) and identify cancer associated biomarkers in cerebrospinal fluid. The Company can also identify biomarkers with testing CTCs and ctDNA in the blood of patients diagnosed with cancer. Identifying biomarkers is necessary for physicians in selecting targeted therapies. Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases during the course of treatment. In January 2020, Biocept announced the commercial availability of its Target Selector cerebrospinal fluid assays for the rapid identification of molecular alterations in brain metastases in patients with primary breast or lung cancer.

The poster presentation today reported higher sensitivity with Target Selector in detecting cancer material and identifying leptomeningeal metastases (cancer in the thin layers of tissue that cover and protect the brain and spinal cord) in cerebrospinal fluid compared with cerebrospinal fluid cytology, the standard-of-care technology.

"Cerebrospinal fluid cytology for the detection of leptomeningeal metastases is the standard, but it often results in false negative results, and lacks sensitivity in detecting biomarkers. These results show Biocept’s Target Selector is a promising tool to meet an underserved need in providing this critical information," said Dr. Kalinsky.

"We are excited to share these data at ASCO (Free ASCO Whitepaper) as they support our belief that Target Selector has potential applicability for identifying actionable mutations in patients with brain metastases allowing physicians the choice to test cerebrospinal fluid, blood or both when looking for biomarker information in order to choose the most appropriate therapy," said Michael Nall, President and CEO of Biocept. "We are planning a larger study to further validate the sensitivity of our Target Selector technology compared with cerebrospinal fluid cytology with the goal of making our platform the standard of care for leptomeningeal metastases testing.

"We’d like to thank Dr. Kalinsky for his continued leadership of this study and others at Biocept who help further validate the use of our technology for the benefit of patients with devastating cancer metastases," he added.

Dr. Kalinsky reports no related financial or conflicts of interest with this study.

About Biocept’s Cerebrospinal Fluid Testing
A medical procedure known as a spinal tap or lumbar puncture is typically performed to collect cerebrospinal fluid when cancer patients present with central nervous system symptoms, for example confusion or dementia. More than 200,000 of these procedures are performed annually in the U.S. Biocept’s Target Selector testing provides an alternative and potentially more accurate means of detecting biomarkers from CTCs or ctDNA of patients with cancer that has metastasized to the central nervous system compared with cerebrospinal fluid cytology. For more information about Biocept’s Target Selector testing, please contact Biocept Customer Services at 888-332-7729.

On May 29, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported the presentation of quality of life and certain safety results from the INVICTUS pivotal Phase 3 study evaluating QINLOCK (ripretinib) in adult patients with fourth-line advanced gastrointestinal stromal tumor (GIST) (Press release, Deciphera Pharmaceuticals, MAY 29, 2020, View Source [SID1234558662]). These results were presented as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program.

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"The recent FDA approval of QINLOCK marked an important milestone for the entire GIST patient community who had been waiting for a new treatment option designed specifically for their disease," said Matthew Sherman, M.D., Executive Vice President and Chief Medical Officer of Deciphera. "In addition to the impressive efficacy results shown in the INVICTUS Phase 3 study, QINLOCK was shown to have a favorable safety profile. Today’s ASCO (Free ASCO Whitepaper) presentations demonstrate that patients receiving QINLOCK rated their overall health, quality of life, and physical and role function as better than that of patients receiving placebo. These insights into the GIST patient experience are invaluable to us as we establish a new standard of care in this area of unmet medical need."

Quality of Life and Self-Reported Function

In a poster presentation titled, "Quality of life (QoL) and self-reported function with ripretinib in ≥4th-line therapy for patients with gastrointestinal stromal tumors (GIST): Analyses from INVICTUS" (abstract 11535; poster 423), five key measures of quality of life and function were maintained in patients with fourth-line GIST receiving QINLOCK compared with declining measures in patients receiving placebo. Patients in the QINLOCK arm had consistently stable patient reported outcomes (PROs), and the measures suggest these patients were able to maintain quality of life while PROs declined sharply in the placebo arm. Additional highlights from the presentation include:

QINLOCK was associated with an increase in the patients’ self-reported health status on the EuroQol-5D visual analogue scale (EQ-5D-5L VAS) while placebo was associated with a decline (p=0.004).
Patients receiving QINLOCK reported better physical and role functioning on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) compared with a decline observed in patients receiving placebo (p=0.004; p=0.001).
Patients receiving QINLOCK had higher perceptions of their overall health and quality of life compared with patients receiving placebo (both p=0.001).
Differences between treatment arms were clinically significant (using threshold for meaningful change).
Patients receiving QINLOCK reported stable scores on all PRO measures out to cycle 10.
Safety and Impact on Patient Reported Outcomes

In a poster presentation titled, "Safety profile of ripretinib, including impact of alopecia and palmar-plantar erythrodysesthesia syndrome (PPES) on patient reported outcomes (PROs), in ≥4th-line advanced gastrointestinal stromal tumors (GIST): Analyses from INVICTUS" (abstract 11539; poster 427), when stratified by alopecia and PPES, patient-reported assessments of function, overall health, and overall quality of life were shown to be stable. This exploratory analysis demonstrates that alopecia and PPES were not associated with a negative effect on function, overall health, and quality of life. Additional highlights from the presentation include:

For both alopecia and PPES, the majority of the events were of lower severity grades and did not generally worsen over time.
In the QINLOCK arm, grade 1-2 alopecia occurred in 44 patients (52%) and grade 1-2 PPES occurred in 18 patients (21%). No patients experienced grade 3 or higher PPES.
There were no serious adverse events of alopecia or PPES reported.
In the QINLOCK arm, 8.2%, 24%, and 7.1% of patients experienced a treatment-emergent adverse event leading to treatment discontinuation, dose interruption, or dose reduction compared with 12%, 21%, and 2.3% in the placebo arm.
A copy of each presentation is available at www.deciphera.com/science/presentation-publications/.

About QINLOCK (ripretinib)

Indications and Usage

QINLOCK (ripretinib) is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. For more information visit QINLOCK.com.

Important Safety Information

There are no contraindications for QINLOCK.

Palmar-plantar erythrodysesthesia syndrome (PPES): In INVICTUS, Grade 1-2 PPES occurred in 21% of the 85 patients who received QINLOCK. PPES led to dose discontinuation in 1.2% of patients, dose interruption in 2.4% of patients, and dose reduction in 1.2% of patients. Based on severity, withhold QINLOCK and then resume at same or reduced dose.

New Primary Cutaneous Malignancies: In INVICTUS, cutaneous squamous cell carcinoma (cuSCC) occurred in 4.7% of the 85 patients who received QINLOCK with a median time to event of 4.6 months (range 3.8 to 6 months). In the pooled safety population, cuSCC and keratoacanthoma occurred in 7% and 1.9% of 351 patients, respectively. In INVICTUS, melanoma occurred in 2.4% of the 85 patients who received QINLOCK. In the pooled safety population, melanoma occurred in 0.9% of 351 patients. Perform dermatologic evaluations when initiating QINLOCK and routinely during treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Continue QINLOCK at the same dose.

Hypertension: In INVICTUS, Grade 1-3 hypertension occurred in 14% of the 85 patients who received QINLOCK, including Grade 3 hypertension in 7% of patients. Do not initiate QINLOCK in patients with uncontrolled hypertension. Monitor blood pressure as clinically indicated. Based on severity, withhold QINLOCK and then resume at same or reduced dose or permanently discontinue.

Cardiac Dysfunction: In INVICTUS, cardiac failure occurred in 1.2% of the 85 patients who received QINLOCK. In the pooled safety population, cardiac dysfunction (including cardiac failure, acute left ventricular failure, diastolic dysfunction, and ventricular hypertrophy) occurred in 1.7% of 351 patients, including Grade 3 adverse reactions in 1.1% of patients.

In INVICTUS, Grade 3 decreased ejection fraction occurred in 2.6% of the 77 patients who received QINLOCK and who had a baseline and at least one post-baseline echocardiogram. Grade 3 decreased ejection fraction occurred in 3.4% of the 263 patients in the pooled safety population who received QINLOCK and who had a baseline and at least one post-baseline echocardiogram.

In INVICTUS, cardiac dysfunction led to dose discontinuation in 1.2% of the 85 patients who received QINLOCK. The safety of QINLOCK has not been assessed in patients with a baseline ejection fraction below 50%. Assess ejection fraction by echocardiogram or MUGA scan prior to initiating QINLOCK and during treatment, as clinically indicated. Permanently discontinue QINLOCK for Grade 3 or 4 left ventricular systolic dysfunction.

Risk of Impaired Wound Healing: QINLOCK has the potential to adversely affect wound healing. Withhold QINLOCK for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of QINLOCK after resolution of wound healing complications has not been established.

Embryo-Fetal Toxicity: QINLOCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 1 week after the final dose. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for at least 1 week after the final dose. QINLOCK may impair fertility in males of reproductive potential.

Adverse Reactions: The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, PPES, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate.

The safety and effectiveness of QINLOCK in pediatric patients have not been established.

Administer strong CYP3A inhibitors with caution. Monitor patients who are administered strong CYP3A inhibitors more frequently for adverse reactions. Avoid concomitant use with strong CYP3A inducers.

Please click here to see the full Prescribing Information for QINLOCK.

About the INVICTUS Phase 3 Study

INVICTUS is a Phase 3 randomized, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK or placebo once daily. The primary efficacy endpoint is progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). QINLOCK also demonstrated a median OS of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).

On May 29, 2020 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) reported that Detailed results from the positive, registrational, randomised controlled Phase II DESTINY-Gastric01 trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and overall survival (OS), a key secondary endpoint, versus chemotherapy (Press release, AstraZeneca, MAY 29, 2020, View Source [SID1234558678]).

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The trial evaluated patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that had progressed following two or more treatment regimens including trastuzumab and chemotherapy.

Gastric cancer is the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease.1,2 Approximately one in five gastric cancers are considered HER2 positive.3,4

The confirmed ORR, assessed by independent central review, was 42.9% with Enhertu monotherapy (6.4mg/kg) compared to 12.5% with investigator’s choice of chemotherapy (paclitaxel or irinotecan). Ten complete responses (CRs) and 41 partial responses (PRs) were seen in patients treated with Enhertu versus no CRs and seven PRs seen in patients treated with chemotherapy.

Patients treated with Enhertu had a 41% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; p=0.0097) at a pre-specified interim analysis. The median OS was 12.5 months versus 8.4 months with chemotherapy. The estimated OS rate at one year in the Enhertu arm was 52.1% and 28.9% with the chemotherapy arm.

Kohei Shitara, MD, Chief of Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan and principal investigator in the Phase II DESTINY-Gastric01 trial, said: "Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are limited options and no approved HER2-targeted therapies. Based on the compelling results of the DESTINY-Gastric01 trial, Enhertu has the potential to become a new standard of care for these patients."

José Baselga, Executive Vice President, R&D Oncology, said: "In DESTINY-Gastric01, the response rate was more than three times higher with Enhertu versus chemotherapy. Additionally, more than half of patients treated with Enhertu were alive at one year compared to less than a third with chemotherapy. In addition to the impressive results we saw in HER2-positive metastatic breast cancer in DESTINY-Breast01, these results in gastric cancer may help further define the role of Enhertu in transforming patient outcomes across multiple HER2-targetable cancers."

Antoine Yver Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, said: "Enhertu is the first HER2-directed therapy to show an improvement in overall survival for patients with previously treated HER2-positive metastatic gastric cancer. These data are encouraging and meaningful since patients with advanced gastric cancer have limited therapeutic options once they progress and face markedly high mortality rates. We are working with regulatory authorities to bring Enhertu to patients with metastatic gastric cancer as quickly as possible."

Enhertu showed a confirmed disease control rate (DCR) of 85.7% versus 62.5% and a median confirmed duration of response (DoR) of 11.3 months versus 3.9 months with chemotherapy.

Summary of results:i

SD, stable disease
i. Data cut-off was 8 November 2019.
ii. Enhertu 6.4mg/kg.
iii. As assessed by independent central review.
iv. ORR is (CR + PR).
v. Confirmed ORR represents responses confirmed by a follow-up scan ≥four weeks after initial CR/PR; unconfirmed ORR is the primary endpoint of the trial (51.3% [95% CI 41.9–60.5] versus 14.3% [95% CI 6.4–26.2]; p<0.0001). Both confirmed and unconfirmed ORR were assessed by independent central review.
vi. DCR is (CR + PR + SD).

The safety and tolerability profile of Enhertu in DESTINY-Gastric01 was consistent with that observed in the Phase I gastric cancer trial and previously reported Enhertu trials.5 The most common Grade 3 or higher treatment-emergent adverse events were decreased neutrophil count (51.2%), anaemia (37.6%), decreased white blood cell count (20.8%) and decreased appetite (16.8%). There were 12 cases (9.6%) of confirmed treatment-related interstitial lung disease (ILD) and pneumonitis as determined by an independent review. The majority were Grade 1 or 2 with two Grade 3, one Grade 4 and no Grade 5 (ILD-related deaths).

The results were presented during the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program and simultaneously published online in The New England Journal of Medicine.6

Enhertu was recently granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric cancer based on data from DESTINY-Gastric01 trial and Orphan Drug Designation (ODD) for patients with gastric cancer, including gastroesophageal junction cancer.

Gastric cancer

Gastric (stomach) cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease; there were approximately one million new cases reported in 2018 and 783,000 deaths.1,2

Approximately one in five gastric cancers are HER2 positive.3,4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers. Gastric cancer is usually diagnosed in the advanced stage, but even when diagnosed in earlier stages of the disease the survival rate remains modest.7 Recommended 1st-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy. For gastric cancer that progresses on 1st-line treatment, there are no other approved HER2-targeted medicines.8

DESTINY-Gastric01

DESTINY-Gastric01 is a registrational Phase II, open-label, multi-centre, randomised controlled trial testing the safety and efficacy of Enhertu versus investigator’s choice of chemotherapy in a primary cohort of 188 patients from Japan and South Korea with HER2-expressing, advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who have progressed on two or more prior treatment regimens including fluoropyrimidine and platinum chemotherapy and trastuzumab. Patients were randomised 2:1 to receive Enhertu or investigator’s choice of chemotherapy (paclitaxel or irinotecan monotherapy). Patients were treated with Enhertu 6.4mg/kg once every three weeks or chemotherapy.

The primary endpoint of the trial is ORR, as assessed by independent central review. ORR, or tumour response rate, represents the percentage of patients whose disease decreased and/or disappears. OS was a key secondary endpoint to be statistically evaluated hierarchically at a prespecified interim analysis if the primary endpoint was statistically significant. Other secondary endpoints include progression-free survival, DoR, DCR and confirmed ORR assessed in those responses confirmed by a follow-up scan of at least four weeks after initial independent central review.9

Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a HER2-directed antibody drug conjugate (ADC) and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

Enhertu (5.4mg/kg) is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.

Enhertu clinical development

A comprehensive development programme is underway globally with six registrational trials evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

In May 2020, Enhertu received BTD from the US FDA for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab and ODD for patients with gastric cancer, including gastroesophageal junction cancer. In March 2018, Enhertu received a SAKIGAKE designation for potential use in the same HER2-positive gastric cancer patient population and a supplemental New Drug Application was recently submitted to the Japan Ministry of Health, Labour and Welfare.

In May 2020, Enhertu also received a BTD for the treatment of patients with metastatic non-small cell lung cancer whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.

Collaboration between AstraZeneca and Daiichi Sankyo

In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and ADCs – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On May 29, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported its latest data at the ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Heat Biologics, MAY 29, 2020, View Source [SID1234558694]). The poster presentation can be viewed on the ASCO (Free ASCO Whitepaper) meeting website at: View Source and on Heat Biologics’ website at: View Source

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HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients’ immune system against multiple cancer testis antigens (CTAs) to elicit a diverse and robust T-cell attack against tumor cells. A Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC) is ongoing, with enrollment of this trial completed in July 2019.

This data demonstrated that significant survival benefit was observed in a cohort of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC; with a median overall survival (mOS) of 28.7 months for the intent-to-treat (ITT) patients (N = 47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting. Notably, a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction (p = 0.0001). Exploratory biomarker analyses showed that overlapping CTA expression in patients’ tumors at baseline with HS-110, as well as the expression of a specific CTA were both associated with statistically significant improved overall survival (p = 0.028 and 0.008, respectively).

"Our exploratory biomarker analysis solidly establishes additional clinical evidence for the HS-110 mechanism of action," said Jeff Hutchins, Chief Scientific and Operating Officer of Heat. "This extended mOS also suggests that HS-110 treatment in combination with a CPI should be considered for any solid tumor type with sufficient CTA overlap with HS-110."

This study has completed enrollment, and 21 of the 47 patients enrolled (45%) are still alive as of this data cut. HS-110 now has a positive safety profile in over 200 patients, and combination of HS-110 and nivolumab appears to be safe and well-tolerated.

"This updated data demonstrates the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC", said Jeff Wolf, Chief Executive Officer of Heat. "Heat is planning an end-of-phase 2 meeting with the FDA to discuss registration trial design."

On May 29, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported data from poster #11511 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, entitled, "Multicenter phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma (Alliance A091401): Results of expansion cohorts (Press release, Tracon Pharmaceuticals, MAY 29, 2020, View Source [SID1234558712])." Investigators from the Alliance for Clinical Trials in Oncology (Alliance), a broad community of scientists and clinicians who are committed to the prevention and treatment of cancer, reported an impressive 29% confirmed objective response rate (ORR) in patients (n=14) with highly refractory Undifferentiated Pleomorphic Sarcoma (UPS) who received Opdivo in combination with Yervoy in a non-comparative randomized trial.

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TRACON recently reported on the results of poster #3021 at ASCO (Free ASCO Whitepaper) 2020, entitled "Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency," which was presented by the Company’s corporate partners, 3D Medicines and Alphamab Oncology, and showed that single agent envafolimab demonstrated a 30.0% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) or those with advanced gastric cancer who failed at least one prior systemic treatment (n=11), who had at least two on-study tumor assessments. The confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.

"The previously reported non-comparative randomized Alliance clinical data indicated that Opdivo combined with Yervoy tripled the ORR in high grade sarcomas compared to single agent Opdivo (ORR of 16% versus 5%). These new data from expansion cohorts indicate that the combination of Opdivo and Yervoy demonstrated a higher ORR than Opdivo alone in UPS, of 29% in highly refractory disease. It has been shown that UPS is one of the sarcoma subtypes with the highest responses to checkpoint inhibitors to date and, given these encouraging combination therapy data, the upcoming ENVASARC pivotal trial is a potentially promising study for patients," said Sandra D’Angelo, M.D., Associated Attending at Memorial Sloan Kettering Cancer Center and lead investigator for the Alliance clinical trial.

"We believe these data bode well for the ENVASARC trial, which will assess the potential of envafolimab as a single agent and in combination with Yervoy in UPS that has progressed following one or two prior lines of treatment," said James Freddo, M.D., TRACON Chief Medical Officer. "Given the ASCO (Free ASCO Whitepaper) 2020 data indicating that envafolimab’s activity is similar to that of Opdivo in MSI-H/dMMR cancer, but without infusion related reactions, we believe our trial’s objective of targeting a 15% ORR in ENVASARC is achievable. Moreover, given the 4% ORR of Votrient, the only approved therapy for refractory UPS and myxofibrosarcoma (MFS), a sarcoma subtype genetically related to UPS that will also be included in ENVASARC, we believe envafolimab combined with Yervoy could provide a transformative new standard of care for sarcoma patients."

The complete envafolimab clinical trial poster is available at: View Source

The complete Alliance clinical trial poster is available at: View Source

About Envafolimab

Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in patients with MSI-H/dMMR cancer, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. 3D Medicines and Alphamab Oncology plans to submit a BLA in China for envafolimab in 2020 based on overall response rate and duration of response in MSI-H/dMMR patients. The submission would be based on the data from the ongoing pivotal phase 2 trial of envafolimab in MSI-H/dMMR cancer.