Seattle Genetics, Takeda: Positive Phase 3 T-Cell Lymphoma Med Results

-ADCETRIS in Combination with Chemotherapy Achieved Primary Endpoint, Demonstrating a Statistically Significant Improvement in Progression-Free Survival Compared to a Standard of Care Chemotherapy-

-Statistically Significant Improvement Achieved in All Key Secondary Endpoints, Including Overall Survival-

-First Randomized Phase 3 Trial to Show Improvement in Overall Survival in Frontline Peripheral T-Cell Lymphoma-

-Data to be Presented at the 2018 ASH Annual Meeting; Global Regulatory Submissions Planned-

Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) announced today that the phase 3 ECHELON-2 clinical trial met its primary endpoint. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) of ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) versus the control arm, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). ECHELON-2 is a global, randomized, double-blind, multicenter trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL), also known as mature T-cell lymphoma (MTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. ADCETRIS is currently not approved for the frontline treatment of PTCL.

Patients in ECHELON-2 were randomized to receive either a combination of ADCETRIS plus CHP or CHOP, a recognized standard of care for frontline PTCL. Results from the trial demonstrated that combination treatment with ADCETRIS plus CHP was superior to the control arm for PFS as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110). The ADCETRIS plus CHP arm also demonstrated superior overall survival (OS), a key secondary endpoint, compared to CHOP (hazard ratio=0.66; p-value=0.0244). All other key secondary endpoints, including PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate and objective response rate were statistically significant in favor of the ADCETRIS plus CHP arm. The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy. Additional data will be presented at the American Society of Hematology (ASH) 2018 annual meeting, December 1-4, 2018, in San Diego, California.

“Peripheral T-cell lymphoma is an aggressive type of non-Hodgkin lymphoma with approximately 4,000 CD30-expressing patients diagnosed every year in the United States,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are excited about the groundbreaking results of the phase 3 ECHELON-2 clinical trial, which demonstrated ADCETRIS in combination with chemotherapy significantly improved treatment outcomes for adult patients with previously untreated CD30-expressing PTCL compared with the current standard of care (CHOP). We’d like to thank the many investigators and patients who participated in this study and contributed to this significant milestone for the PTCL community. We look forward to presenting results at the ASH annual meeting in December and intend to submit a supplemental Biologics License Application to the FDA for approval in this setting in the near future.”

“These clinically meaningful results from ECHELON-2 represent a significant step in the development of a potential frontline treatment in this disease. This trial is the largest randomized, double-blind, phase 3 trial in PTCL,” said Jesús Gomez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “Standard of care in PTCL has not changed in several decades and there remains an unmet need for patients. These data showed a significant improvement in the primary endpoint of progression-free survival and all key secondary endpoints, including overall survival, along with a manageable safety profile. We look forward to sharing these data with regulatory authorities globally.”

Takeda and Seattle Genetics plan to submit these results to regulatory authorities for approval in their respective territories.

https://www.biospace.com/article/releases/seattle-genetics-and-takeda-announce-positive-results-from-phase-3-echelon-2-clinical-trial-evaluating-adcetris-brentuximab-vedotin-in-frontline-cd30-expressing-peripheral-t-cell-lymphoma/

Pfizer Announces Ian Read’s Replacement and Succession Plan

Pfizer announced its succession plan for when Ian Read steps down as chief executive officer on January 1, 2019. The new chief executive officer will be Albert Bourla, who is currently the company’s chief operating officer. Read will stay on as executive chairman of the board of directors.

Read became Pfizer’s chief executive on December 6, 2010, and chairman on December 12, 2011. Under his leadership, the company has marked up 30 drug approvals in the U.S., a total shareholder return of 250 percent, and a direct return of capital to shareholders of more than $120 billion.

He also unsuccessfully attempted two mega-mergers. The first was a 2014 bid to buy UK-based AstraZeneca for $119 billion. This fell apart primarily due to resistance by both the U.S. and UK governments to the deal. In 2016, an attempt to acquire Dublin-based Allergan for $160 billion was dashed when the U.S. Treasury Department implemented new rules regarding tax inversions. A tax inversion is where a U.S. company buys a company based in another country with a very low corporate tax rate, then shifts their headquarters to that country to take advantage of the lower rate. It was estimated that the Allergan deal would have resulted in a $1 billion lower tax rate at the time for Pfizer.

Before taking on the role of chief operating officer on January 1, 2018, Bourla led Pfizer’s Innovative Health business. He also founded the Innovative Health Emerging Markets region, which reported revenues in 2017 of $4.4 billion. Before taking on that role, he was the group president of the Vaccines, Oncology and Consumer Healthcare business unit.

Shantanu Narayen, Lead Independent Director of Pfizer’s board of directors, stated, “Today’s leadership announcement is part of a thoughtful, multi-year success planning process. The board has been impressed with Albert’s performance, depth of experience and track record for success, and we are confident that as chief executive officer he will drive innovation and further advancements across the business.”

The news follows last week’s announcement by Merck & Co that they had rescinded the company’s mandatory retirement age of 65 for its chief executive officer, Kenneth C. Frazier, so he could stay on longer. Leslie A. Brun, lead director for Merck’s board, stated, “CEO succession has been our top priority, and removing the mandatory retirement policy enables the board to make the best decision concerning the timing of the transition.”

Depending on the source, Read is either 64 or 65. Earlier this year, Pfizer offered Read a bigger payday to keep him around until at least March 31, 2019, and also to keep him from working for a competing company through March 31, 2021. This involved a 61 percent increase in compensation to $27.9 million.

In today’s announcement, Read stated, “It’s been an honor to serve as Pfizer’s CEO for the past eight years. However, now is the right time for a leadership change, and Albert is the right person to guide Pfizer through the coming era. Albert is an energizing leader who has an unwavering commitment to serving patients. With 25 years at Pfizer, he has developed an extensive knowledge of the industry and demonstrated an ability to build and grow businesses. With Albert at the helm, our dedicated colleagues across the globe are poised to deliver the next stage of growth. I look forward to working with Albert and the board to continue serving patients and delivering value for shareholders.”

https://www.biospace.com/article/pfizer-announces-ian-read-s-replacement-and-succession-plan/

Dragonfly and Merck Strike $695 Million Deal for Solid Tumors

Waltham, Mass.-based Dragonfly Therapeutics struck a licensing agreement worth up to $695 million with Merck. Merck will license exclusive rights to Dragonfly’s TriNKET technology platform for a number of solid-tumor programs, the company announced today.

Joe Miletich, Merck’s head of discovery and preclinical development, said Dragonfly’s technology platform provides a potential for researchers to harness the power of NC cell receptors. That could lead to the development of novel therapeutics targeting solid tumor indications, Miletich said.

Bill Haney, Dragonfly’s chief executive officer, called Merck a “world leader” in solid tumor cancers. Haney said the company has a history of delivering breakthrough therapy options for patients. He pointed to the company’s TriNKET technology platform as a potential accelerator of developing new drug options.

Dragonfly’s TriNKET (Tri-specific, NK cell Engager Therapies) bind to the proteins expressed on both cancer cells and NK cells. The TriNKET system provides “an active connection between cancer cells, and cells of the immune system including NK cells themselves, T cells, B cells, and other cells that help attack and kill cancer,” according to the company. NK cells are part of the natural immune system of every human body. They also express proteins on their surface.

When the binding occurs, Dragonfly said its TriNKET system stimulates NK cells, which makes them aware of cancerous cells. That stimulation allows the NK cells to both kill the cancer cells, as well as notify other immune cells to attack the cancer. In other words, Dragonfly believes that linking to the natural killer cells and sending them to the cancer cells, it will increase the chances of eliminating the tumors.

“Overall, NK cells amplify the effectiveness of T-cells, acting as a sentinel that calls other immune system cells to attack the cancer, as well as broadening the therapeutic window by using their special characteristics of distinguishing cancer, to more specifically target tumor cells,” Dragonfly said on its website.

Under terms of the agreement, Merck will pay Dragonfly up to $695 million in upfront and milestone payments per program as well as royalties on sales of approved products.

Merck isn’t the first company that Dragonfly has collaborated with. Last year the company struck a five-year agreement with Celgene to develop immuno-oncology therapeutics for hematological cancers based on Dragonfly’s TriNKET technology platform.

Dragonfly was launched in 2015. The company was founded by Tyler Jacks, director of MIT’s Koch Institute, along with Haney, and Natural Killer cell expert, David Raulet. Dragonfly’s own research is still in the preclinical phase. On its website, the company lists a number of assets but does not provide information about the different indications the company is targeting.

https://www.biospace.com/article/dragonfly-and-merck-strike-695-million-deal-for-solid-tumors/

Piper keeps Overweight on Regeneron after Libtayo approval

Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Regeneron Pharmaceuticals (REGN) after Friday’s FDA approval of Libtayo in cutaneous squamous cell carcinoma. Timing is about a month ahead of the late-October FDA action date for Regeneron/Sanofi’s (SNY) PD-1 inhibitor, but a positive decision was expected given the drug’s “compelling data” in advanced CSCC, Raymond tells investors in a research note. While Libtayo will enter the market as the sixth approved PD-(L)1 inhibitor and third approved PD-1 agent, Raymond thinks readouts from the ongoing development program in other indications such as first-line non-small-cell lung carcinoma may make the case for moderate Libtayo uptake.
https://thefly.com/landingPageNews.php?id=2797409

Alnylam initiated at Cantor Fitzgerald

Alnylam initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Alnylam Pharmaceuticals with an Overweight rating and $135 price target.

https://thefly.com/landingPageNews.php?id=2797413

Vertex initiated at Cantor Fitzgerald

Vertex initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Vertex Pharmaceuticals with an Overweight rating and $217 price target.

https://thefly.com/landingPageNews.php?id=2797419

Insys Therapeutics in definitive license agreement with Lunatus for Subsys

Insys Therapeutics announced that it has signed a definitive license agreement with Lunatus for commercialization of Subsys in eight countries in the Middle East. In May, the two companies announced their intent to form an exclusive partnership. This announcement confirms that the definitive agreement has been executed, making Dubai-based Lunatus the exclusive licensee and authorized agent for Subsys in the territory, which comprises Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates.

https://thefly.com/landingPageNews.php?id=2797453