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Corcept Therapeutics - Poster Presentation Abstracts for Treating Cushing's Syndrome & Solid Tumors

06:14 EDT 17 May 2018 | Biotech Watcher


Corcept Therapeutics (CORT) has some ongoing research being reported at the annual meetings for ASCO (American Society of Clinical Oncology) and AACE (American Association of Clinical Endocrinologists).

Background Information

Abstracts were released for ASCO (American Society of Clinical Oncology)


Abstracts were also released for AACE(American Association of Clinical Endocrinologists)

Those with relevance to Corcept are listed below.

Mifepristone Decreases the use of Concentrated U-500 Insulin in Patients with Endogenous Hypercortisolism who have Type 2 Diabetes Mellitus (AACE Poster session, Friday, May 16)

Marked Improvement in Metabolic Parameters in a Patient with ACTH-Independent Hypercortisolism While on Mifepristone (AACE Poster session, Saturday, May 19)

Phenotypic and Metabolic Improvements in a Patient with Equivocal Findings of Hypercortisolism Treated with Mifepristone: Photographic and Radiographic Evidence (AACE Poster session, Saturday, May 19)

Clinical Improvement of ACTH-Dependent Cushing Syndrome of Uncertain Origin in a Patient Switching to Mifepristone Therapy After Multiple Surgeries (AACE Poster session, Saturday, May 19)

Open-Label Phase 2 Study to Assess Safety and Efficacy of Relacorilant (CORT125134), a Selective Cortisol Modulator, in the Treatment of Endogenous Hypercortisolism (AACE Late-Breaking Poster, Saturday, May 19)

Phase 1b: Dose-Finding of relacorilant + Abraxane for Solid Tumors

As of Jan 1, 2018, 25 pts were enrolled; 17 had prior taxane.

Unless the company adds updated information, we see efficacy signals, but we await the additional treatment information. By now, Corcept has viewed additional outcome data.

Most of the 25 patients received lower amounts of medication. These were treatment resistant patients. Furthermore, most had prior taxane treatment.

16 pts received 100 mg relacorilant & 80 mg/m2Abraxane and
1 received 100 mg relacorilant & 60 mg/m2 Abraxane.
4 pts received 200 mg relacorilant &150 mg/m2Abraxane
4 received 150 mg relacorilant & 100 mg/m2 Abraxane.

Safety

Grade ≥3 AEs included neutropenia (40%), anemia (12%), pneumonia (8%), mucosal inflammation (8%), and leukopenia (8%). Dose-limiting toxicity included neutropenia; GCSF support was added to regimens subsequently.

Outcomes

Among patients treated to date:
1 unconfirmed CR (ovarian cancer)
2 confirmed PRs (pancreatic cancer, vulvar cancer)
5 SDs (2 ovarian cancer, 2 pancreatic cancer, 1 carcinoid)

Pancreatic cancer patient with confirmed PR has remained on study 48 weeks, despite having progressed within 14 weeks on earlier gemcitabine/Abraxane combination therapy.

For the 6 patients with available tissue, all had confirmatory GR expression. 4 of 6 patients were responders, and all 4 responders had ≥60% GR staining.

Brief Thoughts

This showed expected efficacy signals within GR+ tumors as well as pancreatic and gynecologic cancer. Given the prior preclinical and clinical studies, this is not a surprise. We await the results from expansion cohorts involving pancreatic and ovarian cancers.

Korlym & Relacorilant for Cushing’s Syndrome

While there were no surprises, we expect the focus to be on the late-breaking abstract for relacorilant to treat Cushing’s syndrome. It should provide a bit more color to the earlier announcements, but nothing earth shaking. Corcept management already gave a terse summary.

Although most of the poster presentations involve single case studies, our eyes focused on the treatment of a brittle diabetic: Mifepristone Decreases the use of Concentrated U-500 Insulin in Patients with Endogenous Hypercortisolism who have Type 2 Diabetes Mellitus.

There is already some evidence that Cushing’s will be found among brittle diabetics. This is a particularly difficult group to treat, and it appears that Korlym (mifepristone) is effective at moderating the disease.

In this study of 34 brittle diabetics, 21 (60%) also had high cortisol levels. Imaging reviewed pituitary and/or adrenal tumors or hypertrophy. 14 of these patients were treated with Korlym; these patients refused surgery or weren’t appropriate for surgery.

After three months of treatment, these patients had a significant decrease in their levels of blood sugar and had a 44% reduction in the average daily dose of U-500 insulin. Although 2 patients were discontinued (due to cortisol withdrawal) and another 5 patients (with renal disease) had a smaller dose, the treatment cohort still maintained its average improvements at 6 months.

As mentioned before, this expands Korlym’s market while providing effective treatment to a difficult-to-treat subset of diabetics.


(At the time this post was written, one or more BioWatch authors held a position in CORT)

This blog post is from The Biotech Watcher:
And about us, see http://alanhobbes.blogspot.com/2014/12/welcome-to-my-personal-thoughts-about.html

Original Article: Corcept Therapeutics - Poster Presentation Abstracts for Treating Cushing's Syndrome & Solid Tumors

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