During their R&D Day call last week, Affimed shared details on the clinical development plan for AFM13 in lymphomas. These future plans were a positive development after the company announced promising early combination data with AFM13+Keytruda in Hodgkin’s Lymphoma at ASH.
Potential Registration Phase 2 Study for Refractory & Relapsed HL Patients
AFM13+Keytruda data at ASH showed that response rates were strong and durable, validating Affimed’s candidate in a salvage setting. In 30 patients, all of whom had failed prior treatment of the standard brentuximab vedotin, AFM13+Keytruda showed an 88% ORR and 46% CR. Additionally, Affimed showed that these responses were durable, presenting 6 month PFS of 77% at the highest dose cohort.
Remember, Keytruda alone is used as an option for these refractory patients. In two studies (Keynote 13 and 87), Keytruda has shown ORRs ~70%, CR of about 25% and 6 month PFS of 72%.
Current HL therapies, such as SGEN’s brentuximab vedotin (Adcetris) and Merck’s Keytruda, are moving to earlier lines of treatment. This presents a need for a new treatment in the salvage (refractory/relapsed) patients who fail these current standards of care.
Affimed is planning a registration study in 2019 for refractory/relapsed patients. The company will discuss a Phase 2 accelerated approval with the FDA and use ASH combination data as support. Focus will then shift to getting AFM+PD-1 combination treatment into Phase 3 studies for earlier lines of treatment (see below)
AFMD mentioned that they are open to a partnership, but wants to keep rights to AFM13. The company is looking to partner AFM13 with a company that is currently developing a PD-1 candidate or already has one approved in the market (Keytruda).
Peripheral T-Cell Lymphoma (2500 patients)
The current standard of care in refractory and relapsed PTCL setting has limited efficacy and high toxicity. ORR is roughly 30% and durability about 7 months. Affimed is running an AFM13 monotherapy study with 3 arms- 2 in PTCL and 1 in a subset of CTCL (see below). In PTCL, AFMD is looking for 40%+ ORR and median durability of 7months. Readouts are expected in mid-2020 with potential accelerated approval (see below).
Mycosis Fungoides - Subtype of Cutaneous T-Cell Lymphoma
Affimed is moving AFM13 monotherapy into a registration study for a subtype of CTCL called mycosis fungoides. This is a small indication with very few patients that currently use SGEN’s BV as a standard and nothing beyond it. As a result, AFMD expects the mycosis fungoides arm to enroll 20 patients and data for potential accelerated approval to be 2H 2018 (see above).
Market Opportunity for AFM13
We believe Affimed’s AFM13 has potential to treat about 3,900 patients annually. The breakdown is
- 3rd line post-BV HL: 1200 patients
- Salvage setting in PTCL: 2500 patients
- Subtype of CTCL: 200 patients
Assuming an annual price of $100,000, which is similar to SGEN’s brentuximab vedotin (Adcetris), that leads to a peak sales figure of ~$400M.
Affimed’s ASH data in HL validated the company’s path in other lymphoma indications. Investors with the patience to wait until 2020 could be rewarded as potential registration studies get underway in 2019. The nearest catalyst is a looming PD-1 partner in the HL indication. Affimed is well funded for 2019. However, with no set near term catalyst and a volatile market, we are staying on the sidelines.
Disclosure: PropThink’s contributors DO NOT have positions in any of the equities mentioned
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