41-14 Vectibix Gets European Approval for Wild-Type RAS Colon Cancer

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Vectibix Gets European Approval for Wild-Type RAS Colon Cancer

The European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI chemotherapy for the treatment of adult patients with wild-type RAS metastatic colorectal cancer.

The new indication is based upon studies that evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is now approved in the European Union for the treatment of adult patients with WT RAS mCRC: in first-line in combination with FOLFOX or FOLFIRI; in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan); and as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

In the U.S., Vectibix is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer as determined by an FDA-approved test for this use: as first-line therapy in combination with FOLFOX; or as a monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Intrexon Corp. signed a cooperative research and development agreement with NCI for the development of adoptive T cell therapies utilizing the RheoSwitch Therapeutic System platform for the treatment of solid tumor malignancies.

The CRADA’s principal goal is to develop adoptive cell transfer-based immunotherapies using NCI proprietary methods for the identification of autologous peripheral blood lymphocytes possessing naturally occurring anti-tumor activity combined with Intrexon’s RTS gene switch for introducing spatially and temporally controlled interleukin-12 expression.

RTS enables transcriptional regulation of a wide variety of therapeutic genes upon dosing of an oral activator ligand veledimex, including in vivo modulation of IL-12 gene expression with a broad dynamic range.

As the first gene switch employed in the clinic to enable dose-dependent cytokine expression and offer the ability to administer or withdraw veledimex for continued treatment cycles, the RheoSwitch platform provides the opportunity to tailor solutions for patient-specific therapeutic effects. Lead anti-tumor ACT/PBL/IL-12 cell therapy candidates will then be clinically evaluated by NCI in patients with metastatic cancer.

Under the CRADA, Steven Rosenberg, chief of the surgery branch in the Center for Cancer Research at the NCI, will be the principal investigator for the study, and Gregory Frost, senior vice president and head of Intrexon’s Health Sector, will serve as co-investigator.

Rubicon Genomics Inc. extended its clinical supply agreement with Agendia for use of its TransPLEX whole genome RNA amplification technology.

Agendia uses the TransPLEX C-WTA kits for the analysis of patient samples for its MammaPrint 70-Gene breast cancer recurrence assay, which recently received 510(k) clearance from FDA. This new three-year agreement follows an earlier contract between the two companies.

Financial details of the agreement were not disclosed. TransPLEX C-WTA kits are manufactured under cGMP and are available for clinical use.

Merck and Pfizer will begin co-promoting Xalkori in the U.S., Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the U.K.

In the U.S. and Canada, Xalkori will be co-promoted by EMD Serono, the US and Canadian biopharmaceutical businesses of Merck.

Xalkori will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the U.S., Canada, Japan and five European Union countries. The second wave will begin in 2016, and includes China and Turkey.

In 2015, Merck will receive a reimbursement associated with its promotion of Xalkori, followed by an 80 percent (Pfizer), 20 percent (Merck) profit sharing on the product starting in 2016. The co-promotion term will last through 2020 for the first wave and from Jan. 1, 2016 through Dec. 31, 2021 in China and Turkey. Pfizer will report the sales of Xalkori in countries where it is co-promoted with Merck.

This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck and Pfizer to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody, to accelerate the development of immuno-oncology medicines for patients with cancer. The immuno-oncology alliance will also advance Pfizer’s PD-1 antibody.


President Joe Biden’s proposed Advanced Research Projects Agency-Health would be a welcome partner to NCI—particularly in conducting large, collaborative clinical investigations, NCI Director Ned Sharpless said.“I think having ARPA-H as part of the NIH is good for the NCI,” Sharpless said April 11 in his remarks at the annual meeting of the American Association for Cancer Research. “How this would fit with the ongoing efforts in cancer at the NCI is still something to work out.”