Xtandi extends survival in late-stage prostate cancer study

Astellas Pharma (OTCPK:ALPMF) and collaboration partner Pfizer (NYSE:PFE) announce final overall survival (OS) data from a Phase 3 clinical trial, PROSPER, evaluating Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in men with non-metastatic castration-resistant prostate cancer.

Treatment with Xtandi + ADT resulted in a statistically significant improvement in OS, a secondary endpoint, compared to placebo + ADT.

In September 2017, the companies announced that the study met the primary endpoint of metastasis-free survival.

https://seekingalpha.com/news/3540490-xtandi-extends-survival-in-late-stage-prostate-cancer-study

Marker up on removal of clinical hold on cell therapy study

Thinly traded micro cap Marker Therapeutics (NASDAQ:MRKR) is up 8% premarket on average volume in reaction to its announcement that the FDA has lifted the clinical hold on its planned clinical trial evaluating its MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia (AML).

The agency instituted the clinical hold in November 2019 citing the need for additional information and technical specifications for two legacy reagents supplied by third parties used in the manufacturing process.

https://seekingalpha.com/news/3540507-marker-up-8-premarket-on-removal-of-clinical-hold-on-cell-therapy-study

FDA clears Varian Medical’s Ethos therapy

Varian Medical Systems (VAR) has received FDA 510(k) clearance for its Ethos therapy, an Adaptive Intelligence solution.

Ethos therapy is an artificial intelligence -driven holistic solution that provides an opportunity to transform cancer care.

This new solution is designed to deliver an entire adaptive treatment in a typical 15-minute timeslot, from patient setup through treatment delivery.

https://seekingalpha.com/news/3540517-fda-clears-varian-medicals-ethos-therapy

Fennec Pharma completes NDA submission for Pedmark

Fennec Pharmaceuticals (NASDAQ:FENC) has completed its rolling submission of a New Drug Application (NDA) to the FDA for PEDMARK (a unique formulation of sodium thiosulfate) for intravenous use.

The company has also submitted a marketing application to the European Medicines Agency for sodium thiosulfate (tradename to be determined).

The PEDMARK indication is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

The FDA has a 60-day review period to determine if NDA is acceptable for filing. If granted a priority review, the PDUFA action date is expected in Q3.

https://seekingalpha.com/news/3540386-fennec-pharma-completes-nda-submission-for-pedmark

Seattle Genetics combo shows positive effect in advanced bladder cancer

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Astellas Pharma (OTCPK:ALPMF) announce updated results from an open-label Phase 1b/2 clinical trial evaluating the combination of antibody-drug conjugate (ADC) PADCEV (enfortumab vedotin-ejfv) and Merck’s Keytruda (pembrolizumab) in previously untreated patients with locally advanced or metastatic urothelial cancer who are ineligible for treatment with cisplatin-based chemo. The data will be presented at the ASCO GU Cancers Symposium in San Francisco.

The objective response rate (ORR) was 73.3% (n=33/45) after a median follow-up period of 11.5 months. The complete response rate was 15.6% (n=7/45). Median progression-free survival (PFS) was 12.3 months. Median overall survival (OS) has not been reached.

On the safety front, 57.8% (n=26/45) of participants experienced a serious or life-threatening treatment-related adverse event. The most common were lipase increase (17.7%), rash (13.3%), hyperglycemia (13.3%) and peripheral neuropathy (4.4%). 17.7% (n=8/45) experienced treatment-related immune-mediated adverse events grade serious or higher that required the use of systemic steroids. There were six discontinuations. There was one treatment-related death due to multiple organ dysfunction syndrome.

The FDA approved PADCEV in December 2019 for locally advanced/metastatic urothelial cancer.

https://seekingalpha.com/news/3540411-seattle-genetics-adc-combo-shows-positive-effect-in-advanced-bladder-cancer

Exelixis’ cabozantinib combo shows encouraging action in prostate cancer

Exelixis (NASDAQ:EXEL) announces positive results from an open-label Phase 1b clinical trial, COSMIC-021, evaluating the combination of Cabometyx (cabozantinib) and Roche’s Tecentriq (atezolizumab) in patients with solid tumors.

Data from the metastatic castration-resistant prostate cancer cohort showed an objective response rate (ORR), the primary endpoint, of 32%, including two complete responders. The disease control rate (responders + stable cancer) was 80%. Median duration of response was 8.3 months, Median follow-up was 12.6 months.

On the safety front, the most common serious/life-threatening treatment-related adverse events were fatigue (7%), diarrhea (7%) and hyponatremia (low sodium levels in the blood) (7%). There was one treatment-related death due to dehydration (90-year-old patient).

Collaboration partner Ipsen (OTCPK:IPSEY) is participating in the study and is contributing funding. Roche is providing product.

The results will be presented on Thursday at the ASCO GU Cancers Symposium in San Francisco

https://seekingalpha.com/news/3540434-exelixis-cabozantinib-combo-shows-encouraging-action-in-prostate-cancer

Karyopharm teams up with Promedico to commercialize Xpovio

Karyopharm Therapeutics (NASDAQ:KPTI) and Promedico, a member of the Neopharm Group, have entered into an exclusive distribution agreement for the commercialization of XPOVIO (selinexor), Karyopharm’s lead SINE compound, in Israel and the Palestinian Authority.

Under the terms of the agreement, Karyopharm will receive certain prespecified payments and is eligible to receive additional payments if regulatory and commercial milestones are achieved by Promedico.

KPTI is also eligible to receive double-digit royalties on future net sales of XPOVIO in the covered territory. In exchange, Promedico will receive exclusive rights to commercialize XPOVIO in the covered territory and is responsible for all regulatory filings and obligations required for registering XPOVIO.

Karyopharm has retained exclusive production rights and will supply finished product for commercial use in the territory.

https://seekingalpha.com/news/3540469-karyopharm-teams-up-promedico-to-commercialize-xpovio