FDA Priority Reviews Highlight Week in Cancer News


Top news of the week in oncology and cancer drug development.

FDA Grants Frontline Atezolizumab Priority Review in Bladder Cancer

The FDA has granted a priority review to the PD-L1 inhibitor atezolizumab (Tecentriq) for use in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (mUC) as a frontline therapy or following progression occurring ≥12 months after neoadjuvant or adjuvant chemotherapy.

The review is based on data from the single-arm phase II IMvigor210 trial. In a study cohort of 119 cisplatin-ineligible, treatment-naive patients, the objective response rate with atezolizumab at a median follow-up of 17.2 months was 23%, including a complete response rate of 9%. Responses occurred regardless of PD-L1 status and across poor prognostic factor subgroups. The median duration of response was not reached. There was an association between tumor mutation load and response.

The median progression-free survival and overall survival were 2.7 months (95% CI, 2.1-4.2) and 15.9 months (95% CI, 10.4 to not estimable), respectively. Under the expedited review, the FDA is scheduled to make a final decision on the application by April 30, 2017. Atezolizumab previously received an accelerated approval as a treatment for patients with locally advanced or mUC whose disease progressed during or after platinum-based chemotherapy.

See more http://www.onclive.com/web-exclusives/fda-grants-atezolizumab-priority-review-for-second-bladder-cancer-indication

Regorafenib Receives FDA Priority Review in Liver Cancer

The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of regorafenib (Stivarga) as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC), according to Bayer, the manufacturer of the multikinase inhibitor.

The sNDA is based on the phase III RESORCE trial, in which the median overall survival was 10.6 months with regorafenib plus best supportive care compared with 7.8 months for placebo plus best supportive care, representing a 38% reduction in the risk of death (HR, 0.62; 95% CI, 0.50-0.78; P <.001). The median progression-free survival was 3.1 months in the regorafenib arm compared with 1.5 months in the placebo group, representing a 54% reduction in the risk of progression or death (HR, 0.46; 95% CI, 0.37-0.56; P <.001).

The median time to progression in the regorafenib group was 3.2 versus 1.5 months with placebo (HR, 0.44; 95% CI, 0.036-0.55; P <.001). Regorafenib is currently approved for the treatment of patients with metastatic colorectal cancer and advanced gastrointestinal stromal tumors.

See more http://www.onclive.com/web-exclusives/fda-grants-regorafenib-priority-review-in-liver-cancer

FDA Lifts Clinical Hold on Pacritinib

The FDA has lifted its clinical hold on trials exploring pacritinib, according to CTI BioPharma, the developer of the JAK2/FLT3 inhibitor. In February 2016, the FDA placed a full clinical hold on pacritinib studies following reports of patient deaths related to intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 myelofibrosis trial.

To rectify the hold, CTI BioPharma provided the FDA with final clinical study reports from the PERSIST-1 and 2 myelofibrosis trials and initiated the new PAC203 trial. The PAC203 study is examining the safety and efficacy of pacritinib in patients with primary myelofibrosis who previously received ruxolitinib (Jakafi). Patients will receive pacritinib at either 100 mg once daily, 100 mg twice daily, or 200 mg twice daily. The targeted enrollment is 105 patients for the trial, which CTI BioPharma will likely launch in spring 2017.

See more http://www.onclive.com/web-exclusives/fda-lifts-clinical-hold-on-pacritinib

PEGPH20 Combo Improves PFS in Pancreatic Cancer

Adding PEGPH20 to standard nab-paclitaxel (Abraxane) and gemcitabine demonstrated improvements in progression-free survival (PFS) compared with nab-paclitaxel/gemcitabine alone for untreated patients with advanced pancreatic cancer, with the best results observed in those with high expression levels of the biomarker hyaluronan (HA), according to new findings from the phase II Study 202 trial presented during a webcast by Halozyme, the company developing the medicine.

Across 279 patients in the study, the primary endpoint of median PFS was 6.0 months in the PEGPH20 arm versus 5.3 months for nab-paclitaxel/gemcitabine (HR, 0.73; 95% CI, 0.53-0.99; P = .045). The overall response rate (ORR) was 40% with PEGPH20 and 33% in the control arm. In those with HA expression on ≥50% of cells, the median PFS was 9.2 months with PEGPH20 (n = 49) compared with 5.2 months in the control arm (n = 35; HR, 0.51; 95% CI, 0.26-1.00; P = .048); however, overall survival (OS) was not significantly improved (11.5 vs 8.5 months; HR, 0.96; 95% CI, 0.57-1.61).

The ORR was 45% with PEGPH20 versus 31% in the control arm. A phase III study, known as HALO 301, is currently assessing PEGPH20 in combination with nab-paclitaxel and gemcitabine for patients with metastatic pancreatic cancer with high HA levels. The primary endpoint of the study is PFS, with secondary outcomes measures focused on toxicity and OS. The use of low weight molecular heparin is mandated in the study.

See more http://www.onclive.com/web-exclusives/pegph20-combo-improves-pfs-in-pancreatic-cancer

Takeda Acquires Ariad

Takeda is buying Ariad for $5.2 billion ($24/share). The deal is expected to be finalized next month. Acquiring Ariad adds brigatinib and ponatinib (Iclusig) to Takeda’s established oncology portfolio. Brigatinib currently has an FDA priority review for use in patients with metastatic ALK-positive non—small cell lung cancer who are resistant to prior crizotinib (Xalkori).

A final approval decision is scheduled by April 29, 2017. Ponatinib has approved indications for the treatment of patients with CML and ALL. Takeda’s existing oncology products include 3 hematology drugs: brentuximab vedotin (Adcetris; approved for Hodgkin lymphoma and ALCL), bortezomib (Velcade; approved for multiple myeloma and mantle cell lymphoma), and ixazomib (Ninlaro; approved for multiple myeloma).

See more http://www.takeda.com/news/2017/20170109_7656.html

Merrimack Sells Onivyde, Generic Doxil to Ipsen

Merrimack has agreed to sell Onivyde (irinotecan liposome injection) and its generic version of Doxil (doxorubicin hydrochloride liposome injection) to Ipsen for up to $1.025 billion plus up to $33 million in net milestone payments retained by Merrimack related to a licensing agreement with Shire.

Onivyde is approved in combination with 5-fluorouracil (5-FU) and leucovorin as a treatment for patients with metastatic pancreatic cancer following prior administration of a gemcitabine-based regimen. Merrimack is now refocusing its R&D on its lead pipeline candidates MM-121 (seribantumab; lung and breast cancer), MM-141 (istiratumab; pancreatic cancer), and MM-310 (multiple solid tumors).

See more http://investors.merrimackpharma.com/releasedetail.cfm?ReleaseID=1006997

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