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Lilly Oncology's partnership with the Loxo research group has been productive(Source:Shutterstock)

The reconfiguration of Eli Lilly and Company’s oncology research and development under the umbrella of Loxo Oncology Inc. has worked out even better than expected, Lilly Oncology president Anne White told Scrip. The R&D team working at what has been rebranded Loxo Oncology at Lilly has delivered a new product Retevmo (selpercatinib) to the parent company’s commercial portfolio and generated positive results for the BTK inhibitor LOXO-305.

“It's actually exceeding my expectations already and it's still early days really, just kind of a year into this experience,” White said. “The speed and the sense of urgency that they brought to our organization has been phenomenal.”

Anne White

Lilly Oncology takes over from the Loxo team as drug candidates move closer to commercialization, starting with Retevmo, which the US Food and Drug Administration approved in May for certain cancers driven by rearranged during transfusion (RET) alterations. The RET inhibitor launched just a few months into the COVID-19 pandemic as patients were putting off doctor visits and delaying treatments to avoid exposure to the novel coronavirus. ()

White said the Retevmo launch remains focused on making sure oncologists are screening their patients for RET alterations, so that they can be treated with Lilly’s drug, if appropriate. She noted that the shift to talking with physicians about drugs in virtual meetings rather than in-person visits largely has been effective in selling oncology products.

However, some patients are still staying home rather than going to the doctor for routine visits and cancer screenings, so White said she worries about the long-term impact for patients.

Targeted Therapy Focus Benefits From Loxo’s Expertise

Cancer screening is particularly important for Lilly’s oncology portfolio, because of the company’s decision to focus on oncology medicines against targets that drive cancer cell growth. Lilly also has an interest in targets that impact immune response. ()

The company recently increased its presence in immuno-oncology by licensing global rights to long-time partner Innovent Biologics, Inc.’s PD-1 inhibitor Tyvyt (sintilimab) on top of the collaborators’ agreement to market the drugs in China. ()

However, targeted therapeutics like Retevmo and the CDK4/6 inhibitor Verzenio (abemaciclib) dominate Lilly’s oncology portfolio. Verzenio was the third drug to market in its class, but it may soon have an advantage other CDK4/6-targeting therapies do not – an indication for the adjuvant treatment of breast cancer. Applications for approval in the adjuvant setting are pending in the US, EU and China. ()

The adjuvant indication will cover high-risk women and men with breast cancer. “In the US, that's a little over 20,000 patients per year. So it's about 50% of the size of the metastatic market that we have when we focus on that high-risk population,” White said. “But the upside is that patients do get treated for longer periods of time and we'll be the only one in that space, so we hope to have really good penetration in that indication once we launch.”

In its earlier-stage pipeline, Lilly is benefitting from the targeted cancer drug development expertise that Loxo cultivated prior to its $8bn acquisition by Lilly in January 2019. Lilly’s cancer R&D shifted to Loxo Oncology at Lilly in December 2019 with former Loxo CEO Josh Bilenker at the helm. ()

Lilly announced during its 29 January fourth quarter earnings call that Bilenker is moving on to pursue new opportunities, but Jake Van Naarden – who was chief business officer at Loxo and served as chief operating officer at Loxo Oncology at Lilly – is taking over Bilenker’s CEO role. ()

“I am incredibly grateful to Josh Bilenker for his leadership in all that we have achieved together,” White said. “I look forward to continuing to work closely with Jake Van Naarden as we deliver on the vision that he, Josh, [SVP and chief scientific officer] Dan Skovronsky and I developed for Lilly Oncology.”

Urgency, Scale And Best-In-Class Focus

She noted that when the Loxo team paired their sense of urgency from their days as biopharma entrepreneurs with Lilly’s scale and commercial expertise, “I had high hopes that together we'd be a pretty powerful force.”

“We really revamped the portfolios in a pretty significant way,” she said. “Loxo's focus is very much on impactful medicines – medicines that work early in development to have that signal early, and then you can move quickly from there and they've done it now repeatedly with Vitrakvi and then Retevmo, and now LOXO-305, which was only in the preclinical stages when we acquired Loxo.”

Vitrakvi (larotrectinib) is a tumor-agnostic therapy that was approved in the US in 2017 to treat solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion and Bayer AG, Loxo’s partner in developing the drug, exercised its option to take on full rights to the drug as Lilly closed the Loxo acquisition. ()

But while Vitrakvi and Retevmo have somewhat limited markets, LOXO-305 has “the potential to be the largest program we've had in Lilly Oncology if it continues to have the same results as it's had to date.”

Lilly reported positive results at the virtual American Society of Hematology (ASH) meeting in December for LOXO-305 in the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). The company is positioning its non-covalent BTK inhibitor as a treatment for patients who have progressed after treatment with first-generation therapies and plans to test LOXO-305 against current blockbuster BTK-targeting drugs in a Phase III study of MCL patients.

Loxo Oncology at Lilly “also moved quickly on early phase portfolios and I'm excited about not just the molecules in development, but we have a number of candidates that will be coming into the clinic this year and next that follow that same philosophy – ones that we think truly have the potential to be best-in-class with early signs of confirmation of efficacy that we're confident in investing in at-risk,” White said.

“What those types of events will allow us to do is to move with the kind of speed that we've seen for Retevmo and with LOXO-305,” she continued. “Retevmo was three years from the first dose to the first launch in the US, because it's that kind of medicine that has response rates of 85%, things that allow you to take advantage of pathways like accelerated approval and other ways to accelerate these kind of game-changing medicines to patients.”

Lilly And Loxo Partner On Business Development

The rush to bring new drugs to patients extends to Lilly Oncology’s business development activities, which it is doing in partnership with the Loxo group.

“I think it's been kind of neat to do this together with Loxo, to really run our business development jointly between early- and late-phase, because molecules can move from early to late pretty quickly in oncology if we can take advantage of the accelerated approval path,” White said.

Lilly and Loxo are focused on bringing in medicines from outside that may be able to show early signs of best-in-class activity.

“We're not doing [business development] based on tumor, like we want to find something in lung or breast cancer; it's more about the attributes of the molecule,” White said. “Does it lend itself to accelerated approval pathways? Is it able to be differentiated early? Do we think that there's some reason that it has a profile that could be best in class?”

However, she acknowledged that oncology business development is “incredibly competitive” with “a lot of companies looking for opportunities in that space and so there's some things that we've wanted to get that we haven't been able to.”

Even so, White said Lilly “is very committed to doing more deals this year,” including acquisitions as well as licensing agreements. Former chief financial officer Joshua Smiley remarked recently that across all of its therapeutic areas, Lilly is hunting for first-in-class and best-in-class assets to fill its R&D pipeline and fuel growth for the next decade.

Smiley recently was replaced by Anat Ashkenazi, who previously served as CFO of Lilly Research Laboratories, after an internal investigation revealed an inappropriate personal relationship between Smiley and another Lilly employee, the company said on 9 February.

Oncology is “obviously a growth area in the pharma industry, [because] it looks like it has growth rates that exceed other therapeutic areas,” but White said “there is still so much unmet need.”

She said Lilly Oncology has “a nice story to tell” potential partners and acquisition targets regarding the increased speed of cancer drug development at the company and the number of new therapies that it has brought to market in recent years.

“I think we've got a pretty good package to offer someone developing a medicine that they want to see reach patients,” White said.

Drug Launches, Product Marketing In A Pandemic

Reaching new patients is more difficult now due to COVID-19, but White said Lilly Oncology’s sales teams shifted rapidly from in-person to virtual meetings with oncologists, including for the launch of Retevmo during the early months of the pandemic.

“It took a lot of ingenuity, a lot of long days to make that shift, but it actually went quite well in the end,” she said. “I think, because it's such an exciting molecule, reaching out to physicians in alternative ways … they were excited to engage with us because this is the first RET inhibitor launched and so they really wanted to learn about it.”

“For Retevmo, there's probably about 6,000 customers in the US that we really wanted to focus on and we have reached the majority of those just within the first few months of launch,” White noted.

Part of the reason that Lilly Oncology adjusted so well to the virtual setting is that the company realized before the pandemic that it needed to engage in virtual interactions more frequently because fewer physician practices are allowing pharma sales reps into their offices.

“We were already pretty agile in this space and I think COVID just accelerated our efforts to make sure we're good at different ways of reaching out to customers beyond the traditional ones,” White said.

She explained that oncologists have been consolidating their practices for a while, particularly in the community setting, so practices have gotten larger and doctors are challenged to see enough patients to make their big practices profitable, leaving little time for pharma sales rep presentations.

“They just really have little time to interact with anyone other than the patients,” White said. “And the other challenge we have in oncology is that there's so much new information, so their ability to kind of keep up with that and go to conferences and other things like that are also limited.”

With fewer patients pursuing cancer screenings, however, cancer treatment has declined, raising the risk that patients will be worse off when they finally do pursue treatment.

“I am concerned [that], in the long run, will we see cancer rates rise because people weren't getting the screening and the testing that they needed? Definitely in Q2 and some in Q3, we did see an impact in the number of new prescriptions for patients,” White said. “We particularly saw an impact in the infused portfolio … where the patients had to come in and get infused in the doctor's office.”

“We saw that doctors were sometimes lengthening the period between the infusions or maybe choosing to put patients on an oral medicine versus an infusion, even though the standard of care might have been an infusion, to try to keep patients out of the doctor's office,” she continued. “But I think we're starting to see things return a bit to normal as physicians and patients realize that cancer may be even more of a threat than COVID.”

Cancer screening numbers seemed to improve in the latter part of 2020 and new prescriptions moved back into a more normal range, and White said “we're hopeful that in 2021 we're going to see a return more to normal levels. Although with this pandemic just going on a bit longer and longer than I think any one of us would have hoped, I think the second half of this year will be more of a return to normal than the first half would be.”


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