Seattle Genetics/Astellas PADCEV: survival benefit in previously treated urothelial cancer

Astellas Pharma (OTCPK:ALPMF) and Seattle Genetics (NASDAQ:SGEN) have announced that a Phase 3 (EV-301) trial of PADCEV (enfortumab vedotin-ejfv) met its primary endpoint of overall survival (OS) compared to chemotherapy, in adult patients with locally advanced/metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

The results were reviewed by an independent Data Monitoring Committee following a planned interim analysis.

PADCEV was approved under the FDA’s accelerated approval program for the same indication in December 2019, based on tumor response rate. The data is expected to support global registrations and convert accelerated to regular US approval.

PADCEV significantly improved OS, with a 30% reduction in risk of death (Hazard Ratio [HR]=0.70), and significant improvement in progression-free survival (PFS) was observed, with a 39% reduction in risk of disease progression or death (HR=0.61).

On the safety front, adverse events included rash, hyperglycemia, decreased neutrophil count, fatigue, anemia and decreased appetite as the most frequent severe events occurring in over 5% of patients.

Patients in the chemotherapy arm of the trial will be offered the opportunity to receive PADCEV.

PADCEV is an antibody-drug conjugate that is directed against Nectin-4.

https://seekingalpha.com/news/3615251-seattle-genetics-astellas-pharmas-padcev-shows-survival-benefit-in-previously-treated

Sanofi, Glaxo finalize deal in Europe to supply 300M doses of COVID-19 vaccine

Following up on their earlier announcement, Sanofi (NASDAQ:SNY) and collaboration partner GlaxoSmithKline (NYSE:GSK) have inked an agreement with the European Commission to supply up to 300M doses of their COVID-19 vaccine after approval.

The EU will provide upfront funding to support the scale-up of manufacturing capacity in Europe. The antigen and final vaccine doses will be made at sites in Belgium, Italy, Germany and France.

A Phase 3 clinical trial should launch by year-end. If all goes according to plan, a regulatory application will be submitted in H1 2021.

The companies, which have also inked supply deals in the U.S. and UK, aim to produce up to 1B doses per year.

https://seekingalpha.com/news/3615252-sanofi-and-glaxo-finalize-deal-in-europe-to-supply-300m-doses-of-covidminus-19-vaccine

Spectrum Pharma: positive new data for poziotinib in lung cancer patients

Spectrum Pharmaceuticals (NASDAQ:SPPI) has announced additional results from its Phase 2 (ZENITH20) trial, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). Data were presented at the European Society for Medical Oncology Virtual Congress.

As reported earlier, Cohort 2 demonstrated a confirmed objective response rate (ORR) of 27.8%, with disease control rate (DCR) of 70%. Median duration of response was 5.1 months, with a median follow-up of 8.3 months and the median progression-free survival was 5.5 months.

The company says tumor reduction occurred in 67 patients (74%), with median tumor reduction of 22%. The evaluable patient analysis (n=74) demonstrated a confirmed ORR of 35.1% with a DCR of 82.4%.

On the safety front, 13 patients (14%) had treatment-related serious adverse events and 11 patients (12%) permanently discontinued due to adverse events. Serious treatment-related rash was observed in 27 patients (30%) with diarrhea in 23 patients (26%). Serious/severe stomatitis/mucosal inflammation occurred in 21 patients (23%).

Company says based on these results it has requested a meeting with the FDA to discuss the data and its plans for a marketing application submission.

Dose interruptions were reported in 78 patients (87%), and dose reductions in 70 patients (78%), which was similar to the rates in Cohort 1.

In December 2019, the primary endpoint for Cohort 1 was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. This amendment did not impact Cohorts 2 and 3 as these were fully enrolled. Top line results from Cohort 3 are expected by the end of the year.

Poziotinib is an oral epidermal growth factor receptor tyrosine kinase inhibitor that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4.

The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.

https://seekingalpha.com/news/3615261-spectrum-pharma-reports-positive-new-data-for-poziotinib-in-lung-cancer-patients

Deciphera QINLOCK shows sustained benefit in gastrointestinal tumor

Deciphera Pharmaceuticals (NASDAQ:DCPH) has announced 9-month follow-up data from the Company’s Phase 3 INVICTUS study of QINLOCK in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) and intra-patient dose escalation data from the ongoing Phase 1 study of QINLOCK in patients with second-line through fourth-line plus GIST.

Data were presented at the European Society for Medical Oncology Virtual Congress.

As of a March 9, 2020 cutoff date, ~9 months from the data cutoff date for the primary analysis, the median PFS remained at 6.3 months versus 1.0 month in the placebo arm (hazard ratio [HR] was 0.16).

The median OS as of the data cutoff was not reached in the QINLOCK arm versus 6.3 months in the placebo arm with a HR of 0.42, as compared to the median OS at the May 2019 data cutoff for the primary analysis of 15.1 months in the QINLOCK arm versus 6.6 months in the placebo arm with a HR of 0.36.

QINLOCK also demonstrated a confirmed objective response rate of 11.8% versus 0% in the placebo arm.

Safety profile was consistent with the previous primary analysis results, demonstrating that QINLOCK was generally well tolerated.

In the ongoing Phase 1 study of QINLOCK in patients with second-line through fourth-line plus GIST, demonstrated that the patients whose dose escalated to QINLOCK 150 mg BID experienced additional clinically meaningful benefit.

QINLOCK is approved by the U.S. FDA, Health Canada, Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors.

https://seekingalpha.com/news/3615268-deciphera-pharmas-qinlock-shows-sustained-benefit-in-gastrointestinal-tumor

AstraZeneca Lynparza shows positive effect in BRCA-mutated ovarian cancer

AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK) announce that LYNPARZA demonstrated a long-term progression-free survival (PFS) benefit versus placebo as a 1st-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who had a complete or partial response following platinum-based chemotherapy.

Five-year follow-up data from the Phase III SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% (based on a hazard ratio [HR] of 0.33; 95% confidence interval [CI] 0.25-0.43) and improved PFS to a median of 56.0 months versus 13.8 months for placebo.

At five years, 48.3% of patients treated with LYNPARZA remained free from disease progression versus 20.5% on placebo.

The median duration of treatment with LYNPARZA was 24.6 months versus 13.9 months with placebo.

The safety profile of LYNPARZA was consistent with previous observations. 12% of patients on LYNPARZA discontinued treatment due to adverse events.

The results were presented at the 2020 European Society of Medical Oncology (ESMO) virtual congress.

https://seekingalpha.com/news/3615269-astrazenecas-lynparza-shows-positive-effect-in-brca-mutated-ovarian-cancer

European advisory group back Pfizer’s Neulasta biosimilar

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Pfizer’s (NYSE:PFE) Nyvepria (pegfilgrastim), a biosimilar to Amgen’s (NASDAQ:AMGN) Neulasta.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3615272-european-advisory-group-back-pfizers-neulasta-biosimilar

Mirati sitravatinib + nivolumab gets 37% response in urothelial cancer

Mirati Therapeutics (NASDAQ:MRTX) has announced updated clinical results from its Phase 2 study evaluating sitravatinib in combination with nivolumab (OPDIVO) in patients with advanced or metastatic urothelial carcinoma. Data were presented at the European Society for Medical Oncology Virtual Congress.

The updated cohort enrolled patients who were previously treated with platinum-containing chemotherapy but were checkpoint inhibitor naïve.

As of the data cut-off on July 30, 30 out of 40 patients were evaluable and findings showed:

Objective response rate of 37%, with 1 patient achieving a complete response (CR) and 10 patients achieving a partial response (PR).

22/30 (73%) patients achieved clinical benefit.

Secondary efficacy endpoints continue to mature with a median follow-up of 8.7 months.

On the safety front, sitravatinib and nivolumab combination has been well-tolerated.

https://seekingalpha.com/news/3615287-mirati-sitravatinib-in-combination-nivolumab-shows-37-response-rate-in-urothelial-cancer