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The oncology sector is slated to heat up in the first half of 2018, with the CAR-T frenzy showing no signs of slowing down. Last year ended with headline-grabbing news from the American Society of Hematology (ASH) meeting in December, which left would-be CAR-T marketers wondering what new revelations will emerge at the American Society of Clinical Oncology (ASCO) meeting in June.
Since the approval of Novartis’ and Gilead’s CAR-T treatments in 2017, healthcare marketers are keeping close tabs on lessons learned from those launches as they gear up for approvals from latecomers Juno Therapeutics and Bluebird Bio. With Novartis’ Kymriah approved for B-cell precursor acute lymphoblastic leukemia and Kite (now owned by Gilead) landing approval for Yescarta for diffuse large B-cell lymphoma (DLBCL), Juno Therapeutics’ JCAR017 will need to seek approval in new indications or demonstrate superior safety data.
Meanwhile, Bluebird Bio’s bb2121 is forging new ground in multiple myeloma. Although the CAR-T jockeying has created a mergers and acquisitions frenzy over small biotechs, Celgene may end up on top thanks to strategic partnerships with both Juno and Bluebird.
Outside of the CAR-T arena, Janssen is making waves with its prostate cancer candidate apalutamide. The drug is being cast as a follow-up to the blockbuster Zytiga — which is slated to go off-patent in October 2018 — but is also considered a standard-of-care improvement via its seeming ability to benefit men who have not yet developed metastatic disease.
As medical marketers start thinking about the messaging strategy around new drugs, they’ll have to keep in mind the price-gouging controversy that continues to roil the business. Novartis, the first company to win approval for a CAR-T candidate, established a baseline by setting Kymriah’s price at $475,000. At the same time, it also rolled out a money-back guarantee if the treatment doesn’t work.
Juno Therapeutics/Celgene, Phase I/II
Indication: Non-Hodgkin’s lymphoma (NHL)
Catalyst: Juno hopes to differentiate its candidate with data presented at the December ASH meeting. The Phase I TRANSCEND trial evaluated two doses of JCAR017 in a core group of 67 NHL patients and full analysis group of 91. Within the core group treated at a higher dose, 14 out of 19 (74%) saw an OR and 13 out of 19 (68%) saw a CR at three months.
Only one patient in the core group experienced severe cytokine release syndrome, while 10 experienced severe neurotoxicity. Tolerability was similar across the full analysis group, with one additional patient experiencing severe neurotoxicity.
Competitive landscape: It’s too early to call where JCAR017 will sit in the CAR-T race vs. Kymriah and Yescarta, notes Chantal Bayard, division manager, health, GfK Switzerland. “Keeping in mind the individual trial populations may not be identical, the DLBCL response data at three months and partly at six months hints at a close competition. Kymriah and Yescarta have shown a complete response of 30% and 31% with JCAR017 at 39%. The picture is similar for objective response rate at 37% and 36% for Kymriah and Yescarta, respectively, and 51% for JCAR017.”
Juno is exploring JCAR017’s ability to be administered in an outpatient setting — an approach that is arguably better for patients and would cut costs. As part of the TRANSCEND trial, investigators treated eight patients at outpatient infusion centers. Most developed fevers, but only one needed treatment.
Juno also plans to test JCAR017 in earlier lines of DLBCL therapy and in third-line chronic lymphocytic leukemia, according to a recent earnings call. Meanwhile, in partnership with Celgene, Juno recently launched the PLATFORM trial, which will explore the combination of JCAR017 and Medimmune and AstraZeneca’s Imfinzi (durvalumab), an approved PD-L1 checkpoint drug, in relapsed or refractory DLBCL.
Messaging strategy: According to Bob Azelby, Juno’s EVP and chief commercial officer, the company is “really confident” it will be able to compete on a toxicity perspective. Azelby notes the potential for outpatient monitoring may also set JCAR017 apart from its peers. Similarly, it could open up the ability to administer the drug outside of academic centers, possibly reaching more patients. “Rather than having to take the patient to the product, we’re excited about the opportunity to take the product to the patient,” he adds.
In addition, Juno is hopeful JCAR017 could become a best-in-class thanks to the “defined composition” – or process by which the company “defines the type, number, and functional profile of the cells that make it into the final product,” per a spokesperson.
Marketing strategy: According to a recent 10-K filing, Juno’s partnership with Celgene comes to play on the global stage, with Celgene agreeing to lead commercialization activities outside North America and China. Juno is also ramping up its own marketing capacity, with Azelby noting it is “building a commercial team that’s very experienced” and “doing a systematic commercial analysis.” He adds: “The marketplace continues to evolve where patients are taking an active approach in decision-making. We anticipate creating channels to access patients, as well as to make sure they’re educated on CAR-Ts and JCAR017, and most importantly that they understand the safety associated with these products.”
Bluebird/Celgene, Phase III
Indication: Multiple myeloma
Catalyst: With new results from an ongoing Phase Ib study announced at ASH, bb2121 affirmed its place as one of the most promising CAR-T cell therapies edging closer to approval. In this study, 17 out of 18 multiple myeloma patients responded to bb2121 after exhausting all other available treatment options. In addition, 56% of patients were in remission more than nine months after treatment.
Meanwhile, only two patients developed cytokine release syndrome, considered one of the biggest risks of CAR-T therapy. In December, Bluebird and Celgene started enrolling patients in a Phase III study that could become bb2121’s pivotal trial.
Competitive landscape: Only multiple myeloma patients who have failed all other options will be candidates. In this small indication, Chinese company Nanjing Legend made waves at the 2017 ASCO meeting with its CAR-T candidate, which led to complete remission in 33 out of 35 patients.
However, Bluebird and Celgene may have an edge in the U.S., given December’s Phase III enrollment. In addition, “safety data presented at ASH 2017 looks promising,” with “no dose limiting toxicities observed,” Bayard notes.
Messaging strategy: “Toxicities, including cytokine release syndrome, have been similar to toxicities observed in CAR T-cell trials for leukemia, including unique acute toxicities that are uncommon with other cancer therapies,” Bayard says. The real selling point for bb2121 may be its high level of complete response.
Marketing strategy: A Celgene spokesperson noted “it’s still too early to talk launch strategy or messaging” for bb2121 and that the company is focusing on its next trial. Still, company executives are clearly thinking about the future (read: multiple myeloma).
Medical marketers should be aware CAR-Ts “are not a slam dunk treatment for all,” cautions Cassandra Sinclair, global client lead at Wunderman Health. “The most successful marketing campaigns will find the right patients and break ‘health inertia’ by engaging the right individuals across the care continuum. This requires a shift from traditional TV campaigns and mass messages that educate to data-driven, personalized marketing and content that motivates action.”
Indication: Castration-resistant prostate cancer
Catalyst: With Janssen’s Zytiga patent set to expire next year, the late-stage candidate apalutamide is in line to buffer lost sales. But apalutamide could be more than just a follow-on: It’s a next-generation oral that stops androgen (the hormonal bogeyman of prostate cancer) from docking on its receptor site.
The Phase III SPARTAN trial met its primary endpoint. Janssen filed for approval in October based on the SPARTAN data and says full results will be made available at a medical meeting in 2018.
Competitive landscape: According to Bayard, “Although it may look similar to other drugs currently on the market, some physicians report it may be an option when they have patients with a rising prostate specific antigen (PSA) under androgen deprivation therapy and without evidence of metastases.”
“Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC,” adds Andree Amelsberg, M.D., VP, oncology medical affairs at Janssen. “Apalutamide would help fill a need in this subset of patients with prostate cancer.”
Messaging strategy: In the SPARTAN trial — the results of which have not yet been made public — the drug was tested in men who experienced an increase in PSA levels even after going through androgen deprivation therapy. If that’s the target market, look for Janssen to position this as a new, earlier option that could delay progression, if trials bear that out.
Marketing strategy: A company spokesperson says it would be “premature” to talk about this publicly. Across pharma, and especially for new product classes, emerging medical marketing trends mean “putting real people and data at the heart of marketing campaigns,” Sinclair notes. “It also means delivering value beyond the pill.” That’s will include supporting patients, playing an active role in adherence and surveillance, forging partnerships with other institutes to create drug cocktails, and fostering connections between patients, caregivers, payers, and brands.